- Market News
UPDATED: COVID-19 Pharma Development TrackerGareth Carpenter — 1 Mar 2021
The latest coronavirus updates and developments impacting the global pharmaceutical supply chain
Track the progress of vaccines and therapies against coronavirus in the various stages of clinical testing:
Countries across the world have started to roll out their vaccination programmes in recent weeks, this infographic from Our World in Data highlights those who are ahead of the curve:
• Johnson & Johnson announces that an advisory body of independent health experts to the US Centers for Disease Control and Prevention has recommended its COVID-19 vaccine for approval. The recommendation will be forwarded to the Director of the CDC and the US Department of Health and Human Services for review and adoption.
• Johnson & Johnson’s single-shot COVID-19 vaccine receives an Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine from the US Food and Drug Administration. Data from a Phase III trial demonstrated it was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application with the FDA later in 2021.
• In a SEC filing, Merck says it has received feedback from the US Food and Drug Administration that additional data would be needed to support a potential EUA application for its investigational COVID-19 treatment, MK-7110. “Based on this FDA feedback, Merck no longer expects to supply the US government with MK-7110 in the first half of 2021,” the company reveals. In December 2020, Merck announced the deal with the US government to support the development, manufacture and initial distribution of MK-7110 upon approval or EUA. Under the agreement, Merck was to receive up to approximately $356 million for manufacturing and supply of approximately 60,000-100,000 doses of MK-7110 to the US government by June 30, 2021.
• The US Food and Drug Administration says it will allow undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF).
• The US government agrees to buy a minimum of 100,000 doses of Eli Lilly’s bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together. The purchase agreement is for $210 million and doses will be delivered through March 31, 2021, with an option for an additional 1.1 million doses through November 35, 2021. The combination recently received emergency use authorization for the treatment of mild to moderate COVID-19 in patients at high risk of progressing to severe COVID-19 and/or hospitalization. Additionally, the National Institutes of Health (NIH) recently updated the COVID-19 Treatment Guidelines to recommend the use of the combination for the treatment of outpatients with mild to moderate COVID-19 at high risk of clinical progression.
• Regeneron says the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for its investigational COVID-19 antibody cocktail, casirivimab with imdevimab and known as REGEN-COVTM in the US, can be used to treat COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
• Albany Molecular Research announces it has been chosen to support the development and manufacture of lipid excipients for the Pfizer-BioNTech COVID-19 vaccine.
• Novavax says it has finalised its agreement with Takeda, originally announced in early August 2020, by signing an exclusive license agreement with the Japanese company to develop, manufacture and commercialize NVX‑CoV2373, Novavax’s COVID‑19 vaccine candidate, in Japan. Additionally, Takeda has dosed the first participants in a Phase II clinical trial to test the immunogenicity and safety of the vaccine in the Japanese population.
• Reporting its FY2020 financial results, Moderna says it has already signed advance purchase agreements for a total $18.4 billion of deliveries of its COVID-19 vaccine in 2021. The company says it is in additional discussions with several governments over APAs for deliveries in 2021 and 2022.
• US President Joe Biden signs an executive order for a review of four essential supply chains, one of which is pharmaceuticals and their ingredients. The idea od the review appears to be to identify weaknesses and ensure security of supply by fortifying domestic supply.
• The European Medicines Agency says its human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (CT-P59), which is being developed by Celltrion, for the treatment of COVID-19. The decision is based on preliminary results from an ongoing study looking at the ability of the medicine to treat COVID-19.
• SK Bioscience, which has tied up deals with AstraZeneca and Novavax to manufacture their COVID-19 vaccines, says it plans to expand its CMO capacity and is seeking to raise about $900 million through an initial public offering.
• Altimmune says it has started enrolment in a Phase I trial of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID, an adenovirus-vector vaccine designed to stimulate a broad immune response in the nasal cavity and respiratory tract.
• COVAX, the equitable global vaccine distribution programme, announces it has shipped 600,000 doses of the AstraZeneca/Oxford University vaccine licensed to Serum Institute of India to Ghana, making it the first country outside India to receive COVID-19 vaccine doses from the COVAX Facility. The delivery is part of a first wave of arrivals that will continue in the coming days and weeks.
• The German health ministry says that the country has administered only 15% of the AstraZeneca/Oxford University COVID-19 vaccine shots it has available. The vaccine is facing public scepticism due to lower efficacy results compared to other approved vaccines.
• Johnson & Johnson’s single-shot COVID-19 vaccine was 66.1% effective at preventing infection at least 28 days after vaccination, with a “favourable safety profile”, according to newly released US Food and Drug Administration briefing documents. The company has filed a request for Emergency US Authorisation based on a Phase III trial of around 44,000 patients.
• AstraZeneca tells the European Union it expects to deliver less than half the COVID-19 vaccines it was contracted to supply in the second quarter, an EU official tells Reuters. The official says the company had told the EU during internal meetings that it would deliver less than 90 million doses in the second quarter. In a statement, AstraZeneca says it is striving to increase productivity to deliver the promised 180 million doses in Q2.
• Aridis Pharmaceuticals says it has adapted its inhaled AR-711 monoclonal antibody with a second mAb (AR-713) that is designed to neutralize newly emerging COVID-19 mutated variants including those from South Africa, Brazil and Japan. Together, the enhanced dual antibody cocktail will be delivered as an inhaled treatment and is on track to start clinical trials in 2H 2021.
• The European Medicines Agency says it has started evaluating an application to extend the use of Gilead’s Veklury (remdesivir) to include treating adults with COVID-19 who do not need oxygen support and a decision is expected before the summer. Veklury is currently authorised for use in adults and adolescents with pneumonia requiring supplemental oxygen.
• Sanofi says it has entered into an agreement with Johnson & Johnson, under which it will support manufacturing of the latter’s COVID-19 vaccine. J&J’s vaccine unit, Janssen, has submitted an application to the US Food and Drug Administration requesting Emergency Use Authorization for the single-dose vaccine candidate and an application for conditional marketing authorisation to the European Medicines Agency. Once authorized, Sanofi will provide access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials in 2021, at a rate of approximately 12 million doses per month.
• Sanofi and GlaxoSmithKline announced they have started a new Phase II study with 720 volunteers to select the most appropriate antigen dosage for Phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.
• Novavax says it has completed enrollment of 30,000 volunteers across 118 sites for PREVENT-19, its pivotal Phase II study in the US and Mexico, to evaluate its COVID-19 vaccine.
• Pfizer and BioNTech say they have submitted new data to the US Food and Drug Administration demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), which would allow it to be stored in pharmaceutical freezers and refrigerators. The data have been submitted to the FDA to support a proposed label change which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer. Currently, the labels for the vaccine including the EUA label in the US state that it must be stored in an ultra-cold freezer at temperatures between -80°C and -60°C (-112°F to ‑76°F).
• Novavax strikes a huge deal with international vaccine alliance, Gavi, to supply 1.1 billion doses of NVX-CoV2373, the biotech’s recombinant protein-based COVID-19 vaccine candidate, for COVAX, the equitable global vaccine distribution programme. The vaccine doses will be manufactured and distributed by Novavax and Serum Institute of India, the latter under an existing agreement between Gavi and SII. The vaccine is currently in Phase III clinical trials in the US, Mexico, and the UK for the prevention of COVID-19. Novavax has previously reported positive interim efficacy results from the UK trial.
• European Union industry commissioner Thierry Breton tells Reuters that COVID-19 vaccine production capacity at a facility in Belgium that produces doses of AstraZeneca’s shot has “drastically increased.” The site, now owned by Thermo Fisher afters its $878.2 million acquisition of Novasep’s viral vector production unit, was cited as the main cause of a large cut in Q1 supplies of the vaccine to the EU.
• Moderna says the European Commission will purchase an additional 150 million doses of its COVID-19 vaccine, scheduled to be delivered in the third and fourth quarter of 2021. This brings its confirmed order commitment to 310 million doses for delivery in 2021. Under the terms of the agreement, the EC has the option to purchase an additional 150 million doses to be delivered in 2022.
• Pfizer and BioNTech seal an agreement with the European Commission to supply an additional 200 million doses of their COVID-19 vaccine, Comirnaty, to the 27 European Union member states. The EC has the option to request supply of an additional 100 million doses. The new agreement is in addition to the 300 million doses that have already been committed to the EU through 2021 under a supply agreement signed last year. The additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in the second quarter.
• The US Food and Drug Administration’s scientific advisory committee will vote next week (26 February) on whether to recommend Johnson & Johnson’s single dose COVID-19 vaccine.
• Australian regulator, Therapeutic Goods Administration, approves the Oxford University-AstraZeneca COVID-19 vaccine for use in Australia. The vaccine has been approved for use in people over 18 but will be given to people over 65 on a case-by-case basis.
• British regulator, the Medicines and Healthcare products Regulatory Agency, is auditing manufacturing processes at Serum Institute of India ahead of a possible move to export doses of AstraZeneca’s COVID-19 vaccine produced at SII’s facility to the UK, according to a Reuters report.
• The US Food and Drug Administration grants an emergency use authorization for Thermo Fisher’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit, a real-time PCR test for the detection and differentiation of RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs.
• In an expansion of its existing manufacturing partnership with Novavax, SK Bioscience has obtained a license to manufacture and commercialize NVX-CoV2373, Novavax’s COVID-19 vaccine, for sale to the Korean government. SK Bioscience will add significant production capacity under this new agreement. Concurrently, SK Bioscience has finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021. Novavax recently reported positive interim efficacy results for the vaccine candidate in an ongoing Phase III clinical trial in the UK and is also currently conducting a Phase III trial in the US and Mexico.
• AstraZeneca’s COVID-19 vaccine is granted Emergency Use Listing by the World Health Organization for active immunisation to prevent COVID-19 in adults, including those over 65. The authorisation enables global access to the vaccine during the pandemic and allows for two doses of the vaccine to be administered at a four to 12-week interval. The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended a dosing interval of eight to 12 weeks. In addition, they also recommended use of the vaccine in countries where new variants, including the South African B1.351 variant, are prevalent.
• BD says the US Food and Drug Administration has granted Emergency Use Authorization for its new molecular diagnostic test for both SARS-CoV-2 and Influenza A+B that can return results in two to three hours. The new test also has been CE marked to the IVD Directive (98/79/EC). The new EUA includes updated information in the test’s instructions for use that addresses variants of the SARS-COV-2 virus, including variants from the UK and South Africa. A computer analysis showed that 99.9% of the genetic sequences of these variants are an identical match to at least one of the two molecular targets for the test.
• Mallinckrodt says it is still waiting on a US Food and Drug Administration decision on StrataGraft, its allogeneic cellularized scaffold product in development for the treatment of patients with deep partial-thickness burns, due to COVID-19-related travel restrictions, which are delaying a required manufacturing site inspection.
• CureVac says the European Medicines Agency has started a rolling review of CVnCoV, the company’s mRNA-based COVID-19 vaccine candidate, currently in late-stage clinical testing. The process was kicked off when the first data package consisting of CVnCoV pre-clinical data was submitted to the EMA and passed the technical validation.
• The US government purchases an additional 100 million doses of COVID-19 vaccines from both Pfizer and Moderna. The orders bring the total vaccine purchased by the US from the two companies to 600 million doses. Each company is delivering 300 million doses in regular increments through the end of July 2021. Moderna says it has supplied 41 million doses to the US to date.
• Novavax is close to signing a COVID-19 vaccine supply deal with the European Union, two EU officials tell Reuters. The EU concluded preliminary negotiations with Novavax in December for the supply of 100 million doses and an option for another 100 million. “Talks with Novavax have intensified and we aim to agree the contract this week or next,” one EU official says.
• Evonik says it is investing in the short-term expansion of its specialty lipids production, essential for mRNA-based COVID-19 vaccines. Commercial lipid quantities are to be produced at Evonik’s Hanau and Dossenheim sites in Germany as early as the second half of 2021 as part of a strategic partnership with vaccine manufacturer BioNTech.
• Roche’s arthritis drug, Actemra (tocilizumab) reduces the risk of death when given to hospitalised patients with severe COVID-19, according to new results from the University of Oxford’s RECOVERY study. The trial showed 596 (29%) of the patients in the tocilizumab group died within 28 days compared with 694 (33%) patients in the usual care group, an absolute difference of 4%. This means that for every 25 patients treated with tocilizumab, one additional life would be saved.
• AstraZeneca says it will build a new COVID-19 vaccine manufacturing facility in Germany after announcing a strategic partnership with German CDMO IDT Biologika. The companies say they plan to invest in capacity expansion at IDT Biologika’s production site in Dessau to build up to five 2,000-litre bioreactors capable of making tens of millions of doses per month of AstraZeneca’s vaccine. The new assets are estimated to be operational by the end of 2022. While details of the agreement are still to be finalised, the partners say they also intend to strengthen Europe’s vaccine manufacturing capability with a joint investment to build future large additional drug substance capacity.
• Recipharm says it has successfully extended its manufacturing license to include immunology products, allowing it to cater for vaccine products at clinical and commercial scales, in both freeze-dried and liquid forms. The license, which applies to its facility in Wasserburg, Germany, also covers microbiological testing allowing the CDMO to insource bacterial endotoxin testing on its products, including testing diluent for one of the COVID-19 vaccines.
• BioNTech says it has started the manufacturing process of mRNA, the active ingredient of its COVID-19 vaccine developed with partner Pfizer, at its Marburg facility. A single mRNA batch of the current scale is sufficient to produce around 8 million vaccine doses, the biotech says. BioNTech plans to start the manufacturing of the drug substance based on the new manufacturing license granted from Darmstadt Regional Administrative Council for the amended facility in Marburg. “We have increased our manufacturing capacity to up to 2 billion doses of our COVID-19 vaccine for 2021, assuming continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers, and the updated six-dose labelling,” the company adds.
• The US Food and Drug Administration grants Emergency Use Authorization for a combination of bamlanivimab and etesevimab to treat mild to moderate COVID-19, Eli Lilly reports. The EUA is based on Phase III data from the BLAZE-1 trial, announced January 26, which demonstrated the combination reduced the risk of COVID-19 hospitalizations and death by 70 percent. Lilly, in collaboration with Amgen, plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021. There are 100,000 doses ready immediately and an additional 150,000 doses will be available throughout the first quarter.
• Japan will lose out on 12 million shots of the Pfizer-BioNTech vaccine because of a shortage of specialist ‘dead space’ syringes capable of extracting a sixth dose from vials. “The syringes used in Japan can only draw five doses,” says Japanese health minister, Norihisa Tamura, according to the Kyodo news agency.
• Verily is partnering with Janssen to launch a COVID-19 Immune Response Study as part of Verily’s Project Baseline. The study aims to collect detailed information about how the coronavirus affects the immune system immediately after someone tests positive for COVID-19. The prospective, exploratory study aims to enroll individuals confirmed positive for SARS-CoV-2 who will participate from home. The study will collect biological measurements, clinical and epidemiological data at the time of COVID-19 testing to characterize longitudinal molecular and/or immunological signatures associated with progression of disease resulting from SARS-CoV-2 infection over 28 days.
• Thermo Fisher says it has launched its high-throughput TaqPath COVID–19 test that is compatible with its Amplitude molecular diagnostic platform. The solution enables laboratories to test up to 8,000 COVID-19 samples a day with fewer staffing requirements and a reliable supply of kits, reagents and consumables. Thermo Fisher now has capacity to produce more than 20 million tests per week.
• In a letter to customers, CDMO CordenPharma says it has instructed all employees and manufacturing facilities to cease and cancel all business travel and face-to-face meetings through the end of Q1 2021, and to convert all scheduled customer meetings into video or teleconference calls “due to the steep increase in COVID-19 cases taking place globally”. In addition, CordenPharma is converting all customer-related quality and SHE audits from in-person to virtual meetings through Q1 2021.
• AstraZeneca/Oxford University’s COVID-19 vaccine does not appear to offer protection against mild and moderate disease caused by the South African 501Y.V2 variant, according to a non-peer-reviewed study, conducted by South Africa’s University of the Witwatersrand and Oxford University. The vaccine’s efficacy against severe COVID-19, hospitalisations and deaths has not yet been determined, the study adds. “Efforts are underway to develop a new generation of vaccines that will allow protection to be redirected to emerging variants as booster jabs, if it turns out that it is necessary to do so,” says Sarah Gilbert, Professor of Vaccinology at the University of Oxford.
• Sinovac Biotech says that the China National Medical Products Administration (NMPA) has granted a conditional marketing authorization for its COVID-19 vaccine, CoronaVac. The approval is based on the results of the two-month data of phase III clinical trials. The final results are not yet available, and efficacy and safety results still need to be confirmed.
• Cadila Healthcare managing director, Sharvil Patel tells analysts that the company has far more orders from various countries for its developmental vaccine, ZyCoV-D, than the capacity it has committed. “In terms of our opportunity size, we have orders far more than what we can make ... I have to work on prioritisation of supplies and manufacturing,” he says.
• World Health Organization director general Tedros Adhanom Ghebreyesus calls on pharma companies to share manufacturing infrastructure to boost the production of COVID-19 vaccines. “We also need a massive scale-up in manufacturing,” he tells a news briefing. “We applaud those manufacturers that have pledged, for example, to sell their vaccines at cost. But manufacturers can do more.”
• CureVac says it has signed a deal with the UK Government to develop and manufacture potential vaccine candidates against SARS-CoV-2 variants. Any resulting vaccine candidates will be manufactured and distributed in the UK and its overseas and dependent territories, subject to regulatory approval. The objective of the collaboration is to mitigate the effects of the current pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines.
• Johnson & Johnson announces that its vaccine subsidiary, Janssen Biotech, has submitted an Emergency Use Authorisation application to the US Food and Drug Administration for its single-dose COVID-19 vaccine candidate. The submission is based on efficacy and safety data from the Phase III ENSEMBLE clinical trial. J&J says it expects to have product available to ship immediately following authorization.
• Daiichi Sankyo says it has signed an outsourcing agreement to manufacture the AstraZeneca/University of Oxford-developed COVID-19 vaccine, AZD1222, in Japan. Daiichi Sankyo will use undiluted solutions provided by AstraZeneca to manufacture COVID-19 vaccines in the country, including vial filling and packaging. Manufacturing will be undertaken at a facility dedicated to the Ministry of Health, Labour and Welfare’s “project to establish a system for developing and producing novel influenza virus vaccines.”
• The Oxford Vaccine Group says it will lead the first trial to explore alternating different COVID-19 vaccines, to explore the potential for flexibility in delivery and look for clues as to how to increase the breadth of protection against new virus strains. The study, run by the National Immunisation Schedule Evaluation Consortium (NISEC) and backed by GBP7 million of UK government funding from the Vaccines Taskforce, will evaluate the feasibility of using a different vaccine for the initial ‘prime’ vaccination to the follow-up ‘booster’ vaccination. This will help policy-makers explore whether this could be a viable route to increase the flexibility of vaccination programmes.
• BD says it has secured the European CE mark of approval for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with expanded clinical application to identify COVID-19 patients who are likely to need to go on a ventilator and at increased risk of death at hospital admission.
• Serum Institute of Institute will supply 1.1 billion doses of COVID-19 vaccines developed by AstraZeneca and Novavax to the COVAX vaccine programme as part of a new long-term deal, says Henrietta Fore, head of the UN Children’s Fund.
• Novavax says it has executed a binding Heads of Terms agreement with the Swiss government to supply 6 million doses of its protein-based COVID-19 vaccine candidate, NVX-CoV2373, to the country. Novavax and Switzerland will negotiate a final agreement, with initial delivery of vaccine doses slated to ship following successful clinical development and regulatory review.
• The European Medicines Agency’s human medicines committee (CHMP) starts a rolling review of NVX-CoV2373, Novavax’s COVID‑19 vaccine. The CHMP says its decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID‑19.
• Humanigen has signed up CDMO Avid Bioservices to manufacture monoclonal antibody lenzilumab, Humanigen’s therapeutic candidate in development for COVID-19. Under the terms of the cGMP agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering drug substance batches to support Humanigen’s regulatory and potential commercial activities. Humanigen has completed enrolment of its Phase III clinical trial of lenzilumab in hospitalized COVID-19 patients.
• GlaxoSmithKline and CureVac announce a new €150m collaboration to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. GSK will also support the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate CVnCoV in 2021. Through the exclusive co-development agreement, GSK and CureVac will contribute resources and expertise to research, develop, and manufacture novel mRNA vaccine candidates, including multi-valent and monovalent approaches. The development programme will begin immediately, with the target of introducing the vaccine in 2022, subject to regulatory approval.
• The US Food and Drug Administration has issued a complete response letter to Eagle Pharmaceuticals for its Abbreviated New Drug Application for vasopressin to treat COVID-19. The company says it has now had two conversations with the FDA regarding the CRL and will have an additional meeting with the regulator within 30 days. In its communication with Eagle, FDA restated that it has prioritized Eagle’s ANDA, and it is also flagged as a COVID priority. Eagle says it can “fully respond to the questions raised.”
• CDMO Catalent says “COVID-19-related programs were the primary contributors to growth” as it announces a 79% year-on-year jump in its biologics segment’s net revenue.
• Novavax announces it has signed an MOU with the Canadian government to produce NVX-CoV2373, its protein-based COVID-19 vaccine candidate in Canada. Novavax plans to produce the vaccine at the National Research Council’s Biologics Manufacturing Centre in Montréal once both the vaccine candidate and the facility receive Health Canada approvals.
• Australian digital diagnostics company Ellume announces a $231.8 million agreement with the US government to accelerate domestic US production of its COVID-19 home tests. The Ellume COVID-19 Home Test is the first rapid self-test for COVID-19 detection authorized by the US Food and Drug Administration for both asymptomatic and symptomatic use without a prescription.
• Johnson & Johnson plans to ship some vaccines ordered by the European Union to the US for fill and finish, raising concern among some member states that the bloc’s inoculation program could be beset by further delays, according to a diplomatic note seen by Bloomberg. One senior EU official told ambassadors that doing some fill and finish in the US was a condition of the contract with the pharma firm and it was committed to delivering on schedule, according to the note.
Clover Biopharmaceuticals ends its COVID-19 vaccine partnership with GlaxoSmithKline after deciding to stick with Dynavax’s adjuvant following the results of a Phase I trial. The company says that based on “the positive Phase 1 clinical trial results and scale-up manufacturing considerations”, it plans to initiate a global Phase 2/3 study to evaluate the safety and efficacy of S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s advanced adjuvant CpG 1018 plus alum within the next few months. “Having fully evaluated all available data, and based on our discussions with Clover and CEPI, we will not progress this collaboration using GSK’s pandemic adjuvant,” GSK says in a statement.
• Bayer says it plans to add an additional 160 million doses of CureVac’s mRNA vaccine in 2022 to further expand their supply network and overall capacity using the manufacturing network of Bayer. First commercial product from this expansion may already be available towards the end of 2021. “Following discussions with the German government it has become clear that current manufacturing capacities for vaccines need to be increased, particularly for potential variants of the SARS-CoV-2 virus,” the company says in a joint statement with the German health ministry.
• European Commission President, Ursula von der Leyen says that AstraZeneca will deliver 9 million additional doses of its COVID-19 vaccine to the EU in the first quarter, bringing the total to 40 million, and will start deliveries one week earlier than scheduled. The company will also expand its manufacturing capacity in Europe.
• The European Medicines Agency releases its first safety update on a COVID-19 vaccine — Pfizer and BioNTech’s Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified.
• Johnson & Johnson says that in a Phase III trial among participants from different geographies and including those infected with an emerging viral variant, its COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the US, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.
• The European Medicines Agency recommends granting a conditional marketing authorisation for AstraZeneca/University of Oxford’s COVID-19 shot, the third COVID-19 vaccine to be approved by the regulatory agency. “With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” says Emer Cooke, Executive Director of EMA.
• Novartis says it has signed an initial agreement to leverage capacity at its aseptic manufacturing facilities at its site in Stein, Switzerland to support production of the Pfizer-BioNTech COVID-19 vaccine. Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for global distribution. Subject to reaching a final agreement, Novartis plans to start production in the second quarter of 2021, with first shipment of finished product expected in the third quarter. Novartis adds it is in advanced discussions with several companies to take on manufacturing activities such as mRNA production, therapeutic protein production as well as raw material production for COVID vaccines and therapeutics.
• Italy’s special commissioner for the COVID-19 pandemic, Domenico Arcuri says Moderna has informed him that its vaccine deliveries to the country will be cut by 20% from 166,000 doses to 132,000 in the week beginning 7th February. He says that after similar moves by Pfizer and AstraZeneca, Italy is now missing more than 300,000 scheduled vaccine doses.
• In an interview with German radio station, Deutschlandfunk, European Commission President Ursula von der Leyen dismisses claims by AstraZeneca that the company is only obliged to make “best effort” commitments to supply its COVID-19 vaccine to the EU due to production issues. “’Best efforts’ meant as long as it was not clear whether [AstraZeneca] can develop a vaccine. We have now passed that time,” she says.
• The European Commission says AstraZeneca has agreed to publish a redacted version of the COVID-19 vaccine contract signed between the two parties last August. “The Commission welcomes the company’s commitment towards more transparency in its participation in the rollout of the EU Vaccines Strategy,” the EC says in a statement. “Transparency and accountability are important to help build the trust of European citizens and to make sure that they can rely on the effectiveness and safety of the vaccines purchased at the EU level. The Commission hopes to be able to publish all contracts under the Advance Purchase Agreements in the near future.”
• Germany’s Standing Committee on Vaccination (STIKO) says AstraZeneca’s COIVD-19 vaccine should not be given to people older than 65 years, citing a lack of evidence of efficacy in the age group. “Due to the small number of study participants in the age group ≥65 years, no conclusion can be made regarding efficacy and safety in the elderly. This vaccine is therefore currently recommended by STIKO only for persons aged 18-64 years,” the panel says in its recommendation. In response, AstraZeneca describes the STIKO recommendation as “not an accurate reflection of the totality of the data.”
• Novavax announces that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, reached efficacy of 89.3% in its Phase III clinical trial in the UK and was also effective against the highly-contagious UK variant strain of the virus.
• Experts from Belgium’s Federal Agency for Medicines and Health Products inspect Novasep’s facility in Seneffe -- which produces AstraZeneca’s COVID-19 vaccine -- at the request of the European Commission in a bid to establish whether projected delays are due to production issues.
• European health commissioner Stella Kyriakides hits back at AstraZeneca’s claims that not only is there a priority clause in the advance purchase order it signed with the pharma company for supply of its COVID-19 vaccine but also a stipulation that UK facilities must prioritise domestic deliveries over exports to the EU. “Not being able to ensure manufacturing capacity is against the letter and the spirit of our agreement,” she says. “We reject the logic of first come, first served. That may work at the neighbourhood butchers, but not in contracts. And not in our Advance Purchase Agreements. There's no priority clause in the Advance Purchase Agreement. And there's also no hierarchy of the four production plants named in the Advance Purchase Agreement.”
• Sanofi says it has agreed to support manufacturing and supply of BioNTech’s COVID-19 vaccine which is being co-developed with Pfizer. Sanofi will perform late-stage manufacturing to supply over 125 million doses of the COVID-19 vaccine for the European Union. Initial supplies will originate from Sanofi’s production facilities in Frankfurt from summer of 2021.
• Lonza will soon start two new manufacturing lines for Moderna’s COVID-19 vaccine, but it will take around two months to reach “cruising speed”, CEO Pierre-Alain Ruffieux tells Reuters. The CDMO has built capacity for 400 million does per year of the vaccine, at its facilities in the US and Switzerland.
• Abbott says it has received European approval for two new uses of its Panbio COVID-19 Ag lateral flow test for the detection of the SARS-CoV-2 virus: asymptomatic testing and self-swabbing. Panbio COVID-19 Ag's label has been updated with clinical data on asymptomatic individuals, which enables mass testing of people who do not currently present symptoms of the disease. The other update to the label allows self-collection of nasal specimens under the supervision of a healthcare worker.
• Moderna confirms it is in discussion with the US government to purchase an additional 100 million doses of its COVID-19 Vaccine for delivery in the third quarter of 2021, on top of the 200 million doses it has already secured.
• Regeneron Pharmaceuticals announces positive initial results from an ongoing Phase III clinical trial evaluating REGEN-COV (casirivimab and imdevimab antibody cocktail) used as a “passive vaccine” for the prevention of COVID-19 in people at high risk of infection. Passive vaccination with REGEN-COV resulted in 100% prevention of symptomatic infection and approximately 50% lower overall rates of infection. Confirmatory Phase III results are expected early in the second quarter.
• AstraZeneca labels stories by German newspapers Bild and Handelsblatt claiming that its COVID-19 vaccine is only 8% effective in people over 65 “completely incorrect.” The German health ministry clarifies that 8% of patients in the AZ trial were between the ages of 56 and 69, which may have been confused with efficacy data.
• The European Commission announces plans to monitor the export of COVID-19 vaccines from the block. Under the new rules, pharma companies would have to provide early notification of exports of all vaccines manufactured in the bloc, says European health commissioner, Stella Kyriakides.
• Johnson & Johnson says it expects to report Phase III clinical trial results of its COVID-19 vaccine by early next week, and to deliver 100 million doses for use in the US by the end of H2, dependent on regulatory authorisation.
• European Health Commissioner Stella Kyriakides says AstraZeneca’s newly-revised delivery schedule of its COVID-19 vaccine to EU member states – which significantly lowers the number of doses being shipped in the coming weeks is unacceptable. “The European Union has pre-financed the development of the vaccine and the production and wants to see the return,” she says in a statement. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered.” The European Commission has proposed to the 27 Member States that an export transparency mechanism be put in place as soon as possible. EU approval of the vaccine is expected by the end of January.
• Moderna says results from studies of sera from individuals vaccinated with its mRNA COVID-19 vaccine indicate that it remains effective against emerging strains of SARS-CoV-2, including the more contagious so-called UK variant. However, it is less effective against the South Africa strain, B.1.135, and so the company is advancing an emerging variant booster candidate.
• Humanigen has hired CDMO Emergent BioSolutions to accelerate the drug product manufacturing of monoclonal antibody, lenzilumab, designed to prevent and treat cytokine storm. Under the terms of the agreement, Emergent will manufacture drug product batches to support increased supply of lenzilumab in anticipation of a potential EUA beginning in the first quarter of 2021, including utilization of a new flex fill line at Emergent’s Baltimore drug product manufacturing facility. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19.
• Civica Rx announces plans to build a 120,000 square-foot manufacturing facility in Petersburg, Virginia, producing sterile injectable medications used in hospitals for COVID-19 patient care, emergency room and intensive-care unit treatments, surgeries, and to treat other serious conditions.
• AstraZeneca says that if EU approval is granted for its COVID-19 vaccine, “initial volumes will be lower than anticipated” due to “reduced yields” at a facility in Belgium run by partner Novasep. AstraZeneca had originally planned to deliver 80 million doses to the EU in the first quarter, but this could be cut to 31 million. A further 80 million doses are contracted for Q2, although AZ is not able to indicate delivery targets for the quarter due to the production issues. “EU Commission and Member States expressed deep dissatisfaction with this,” tweets European Health Commissioner Stella Kyriakides. “We insisted on a precise delivery schedule on the basis of which Member States should be planning their vaccination programs, subject to the granting of a conditional marketing authorisation.”
• Novavax announces it has finalized an agreement with the Canadian government to supply up to 76 million doses of its COVID-19 vaccine, NVX-CoV2373. Canada has committed to purchase 52 million doses with the option for up to an additional 24 million. NVX-CoV2373 is currently in Phase III clinical trials and Novavax expects deliveries to Canada to start as early as the second quarter of 2021, dependent on authorization by Canada’s regulatory agency.
Pfizer and BioNTech announce an advance purchase agreement with global equitable vaccine access initiative COVAX for the delivery of up to 40 million doses of their COVID-19 vaccine throughout 2021. The first doses are expected to be delivered in the first quarter, subject to the negotiation and execution of supply agreements under the COVAX Facility structure. For 92 low- and lower-middle-income countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price.
• Flooding is averted at Wockhardt’s manufacturing facility in Wrexham, Wales – which is currently producing supplies of AstraZeneca and Oxford University’s COVID-19 vaccine -- after emergency teams work through the night to stop it being inundated. “Further to reports on flooding in the Wrexham area, Wockhardt UK also experienced mild flooding yesterday. All necessary actions were taken with no disruption to manufacturing. We would like to reassure everyone that the site is secure and operating as normal,” Wockhardt UK tweets.
• Five people lose their lives after a fire breaks out at Serum Institute of India’s manufacturing facilities in Pune. “Today is an extremely sorrowful day for all of us at Serum Institute of India. Regrettably, there were losses of lives in the fire that broke out in our under installation facility situated at the Special Economic Zone at Manjri,” tweets Cyrus Poonawalla, Chairman & Managing Director, Serum Institute of India. The company says shipments of Covishield, the AstraZeneca-Oxford University COVID-19 vaccine which it is manufacturing locally, are unaffected.
• Eli Lilly says that in a Phase III trial, its monoclonal antibody therapy, bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among care home residents and staff. For the residents subgroup, those receiving bamlanivimab have up to an 80% lower risk of contracting COVID-19 versus residents taking a placebo, the company says.
• Italy is ready to take legal action against Pfizer for recent delays in delivery of its COVID-19 vaccine, according to the country’s special commissioner for the COVID-19 pandemic, Domenico Arcuri. He says weekly deliveries of the shot are down 29% this week and predicted to be 20% lower next week.
• Pfizer and BioNTech announce encouraging results from an in vitro study on the capability of their COVID-19 vaccine, BNT162b2, to neutralise the rapidly spreading UK variant of the coronavirus, also known as B.1.1.7 lineage or VOC 202012/01. The companies have previously published data from an in vitro study that evaluated one of the key mutations (N501Y) in the UK strain, which is also shared by the South African strain. That study showed efficient neutralization of the N501Y mutated spike bearing virus by sera of individuals who had received the Pfizer-BioNTech COVID-19 vaccine. The current in-vitro study investigated the full set of UK strain spike mutations. “The preserved neutralization of the pseudovirus bearing the UK strain spike by BNT162b2-immune sera makes it likely that COVID-19 caused by the UK virus variant will also be prevented by immunization with BNT162b2,” the companies say.
• Thermo Fisher Scientific agrees to buy Mesa Biotech, a privately held molecular diagnostic company which has developed and commercialised a PCR-based rapid testing platform for infectious diseases including SARS-Cov-2, for approximately $450 million in cash. Under the terms of the agreement, Thermo Fisher will pay up to an additional $100 million in cash upon the completion of certain milestones following the close of the transaction.
• New York state governor Andrew Cuomo calls on Pfizer to bypass the US federal government’s Operation Warp Speed programme and sell doses of its COVID-19 vaccine directly to the state. “The distribution of any doses obtained directly from Pfizer will follow the rigorous guidance the State has established, while enabling us to fill the dosage gap created this week by the outgoing federal administration,” Cuomo writes in a letter to the pharma firm. In a statement, Pfizer says it is open to collaborating with the US Department of Health and Human Services “on a distribution model that gives as many Americans as possible access to our vaccine as quickly as possible. However, before we can sell directly to state governments, HHS would need to approve that proposal based on the EUA granted to Pfizer by the FDA.”
• Pfizer and BioNTech say they have developed a plan that will allow the scale-up of manufacturing capacities in Europe and deliver significantly more doses of their COVID-19 vaccine in the second quarter. As a result, their facility in Puurs, Belgium will experience a temporary reduction in the number of doses delivered in the upcoming week, the companies say, adding that they will be back to the original schedule of deliveries to the European Union beginning the week of January 25, with increased delivery beginning the week of February 15.
• Swedish biotech Cyxone says the first patient has been screened in a Phase II clinical trial of its rheumatoid arthritis drug, Rabeximod, to treat COVID-19. The trial will evaluate the efficacy and safety of the oral treatment to prevent disease progression in hospitalized COVID-19 patients and shorten the time to recovery. The study will include 300 patients at clinical centers in Poland, Slovakia and up to three additional countries in Europe. Cyxone expects to announce preliminary results in the third quarter of 2021.
• With the COVID-19 pandemic exposing the issue of clinical trial diversity, Parexel and Signify Health announce a strategic collaboration focused on improving patient access to clinical trials, bringing studies to patients in their own homes, and identifying relevant social determinants of health to facilitate connections among local resources, patients, and caregivers. “Simply saying clinical trial diversity is ‘important’ is not enough,” says Peyton Howell, Executive Vice President and Chief Commercial & Strategy Officer for Parexel. “To correct the disparities in healthcare and drive more inclusion in clinical trials, we first must achieve a more holistic understanding of the non-medical factors that influence patient lives.”
• Australia’s CSL says it remains committed to producing AstraZeneca and Oxford University’s COVID-19 vaccine, despite calls from some scientists in the country to suspend rollout due to concerns about efficacy. “We anticipate that the first locally produced doses of the vaccine will be ready in the second quarter of 2021, subject to regulatory approval. As such, CSL is fully focused on the safe and effective production of the AstraZeneca vaccine,” CSL says in a statement.
• Pfizer is increasing its 2021 production goal from 1.3 billion COVID-19 vaccine doses to 2 billion, Albert Bourla, Pfizer chairman and CEO, Albert Bourla says in an investor call.
• Regeneron says the US government has agreed to purchase additional supply of its antibody cocktail for use in non-hospitalized COVID-19 patients. Under the new agreement, the government will purchase all finished doses delivered by June 30, 2021, up to 1.25 million doses, adding to a previous agreement, whereby Regeneron is already supplying doses to treat approximately 300,000 people.
• The European Medicines Agency says it has received an application for conditional marketing authorisation for AstraZeneca and Oxford University’s COVID-19 vaccine. The assessment will proceed under an accelerated timeline and an opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP).
• The EMA also says that an ongoing investigation of a cyberattack on the agency in early December revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties have been leaked on the internet. Necessary action is being taken by the law enforcement authorities, the EMA says.
• Swissmedic, the Swiss Agency for Therapeutic Products, has authorized Moderna’s COVID-19 vaccine for use in Switzerland. The Swiss Federal Government has secured 7.5 million doses and first deliveries are expected to begin in January.
• Albany Molecular Research (AMRI) says its Albuquerque, New Mexico facility has been approved for inclusion in the Biomedical Advanced Research and Development Authority (BARDA) CDMO network, part of an effort by the US government to improve preparedness capabilities. AMRI’s Albuquerque location includes a large-scale fill and finish facility, currently supporting COVID-19 vaccine production.
• Valneva says it is in advanced discussions with the European Commission for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001, the only inactivated vaccine candidate in clinical trials against the virus in Europe. VLA2001 entered Phase 1/2 clinical studies in December and Valneva expects to report initial safety and immunogenicity data in April 2021. If clinical development is successful, an initial approval could be granted in the second half of 2021.
• Baxter BioPharma Solutions says it will provide sterile manufacturing services for NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, which is currently in Phase III trials. The contract manufacturer, which specialises in parenteral (injectable) pharmaceuticals, including vaccines, will operate from its facility in Halle/Westfalen, Germany.
• Merck KGaA expands its lipid manufacturing expertise with the acquisition of AmpTec, a Germany-based, mRNA CDMO. Merck says the acquisition will boost its ability to develop and manufacture mRNA for use in vaccines, treatments and diagnostics applicable in COVID-19 and many other diseases.
• Fujifilm Diosynth Biotechnologies and the Texas A&M University System Center for Innovation in Advanced Development & Manufacturing (CIADM) announce that production has begun on two different COVID-19 vaccine candidates after FDB recently completed its capacity expansion at its flexible biomanufacturing facility in College Station, Texas, to accommodate large-scale production. FDB will produce bulk drug substance of NVX‑CoV2373, Novavax’ vaccine candidate, which began phase III clinical testing in the US and Mexico in December. NVX-CoV2373 is already being manufactured at commercial scale at the company’s plant in Morrisville, North Carolina.
• The UK Medicines and Healthcare products Regulatory Agency grants regulatory approval to Moderna’s mRNA-1273, the third COVID-19 vaccine to be approved for uuse by the MHRA.
• The Australian government signs an agreement to purchase 51 million doses of Novavax’s experimental COVID-19 vaccine, the company says in a regulatory filing. Australia will have the option to purchase up to an additional 10 million doses, with the initial doses expected to be delivered by mid-2021, the company says.
• Bayer will support CureVac on the further development, supply and key territory operations of its COVID-19 vaccine candidate, CVnCoV, the companies announce. Bayer will contribute its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance as well as support in selected countries.
• Aspen Pharmacare could start manufacturing Johnson & Johnson’s COVID-19 vaccine in South Africa by late March or early April dependent on approvals, Stavros Nicolaou, Group Senior Executive, Strategic Trade at the company tells Reuters. Aspen currently has capacity to manufacture up to 300 million doses.
• The European Medicines Agency’s human medicines committee (CHMP) recommends granting a conditional marketing authorisation for Moderna’s COVID-19 vaccine. The final step to full EU approval rests with the European Commission, which is expected to give the green light quickly.
• Moderna increases its base-case global production estimate for its mRNA-1273 COVID-19 vaccine from 500 to 600 million doses for 2021. The biotech says it is continuing to invest and add staff to build up to potentially 1 billion doses for 2021 and expects about 100 million doses to be available in the US by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. Approximately 18 million doses of mRNA-1273 have been supplied to the US Government since the vaccine received Emergency Use Authorization from the US Food and Drug Administration on December 18. Additional vaccine doses have also been supplied to the Canadian government following authorization by Health Canada's Interim Order on December 23, 2020.
• The UK starts its inoculation programme for the AstraZeneca-Oxford coronavirus vaccine. Doses of the vaccine will initially be delivered at "a small number of hospitals for the first few days for surveillance purposes," before the bulk of doses arrives at medical practices later in the week, says the country’s National Health Service.
• The European Medicines Agency says it will continue discussions about authorising Moderna’s COVID-19 vaccine on 6th January. “EMA’s committee for human medicines (CHMP) discussion on COVID-19 vaccine Moderna has not concluded today. It will continue on Wednesday 6th January 2021. No further communication will be issued today by EMA,” the agency tweets.
• India’s drug regulatory authority approves the emergency use of two coronavirus vaccines developed by AstraZeneca and Oxford University and local company, Bharat Biotech. The Oxford/AstraZeneca vaccine is being manufactured in India by the Serum Institute of India.
• The UK Medicines and Healthcare products Regulatory Agency approves AstraZeneca’s COVID-19 vaccine for emergency supply in the UK, with the first doses being released so that vaccinations can begin early in the New Year. The authorisation recommends two doses administered with an interval of between four and 12 weeks. AstraZeneca says it is working with Public Health England and National Health Service England to support the deployment and roll out of the vaccine in the UK, and aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total.
• Colombia agrees to buy 9 million doses of Johnson & Johnson’s coronavirus vaccine, President Ivan Duque says in a televised address.
• Pfizer and BioNTech agree to supply an additional 100 million doses of their COVID-19 vaccine, Comirnaty, to the European Union in 2021, bringing the total number of doses to be delivered to the EU to 300 million. The European Commission decided to exercise its option to purchase the extra doses under its advanced purchase agreement signed on 11 November.
• Pfizer and BioNTech announce a second agreement with the US government to supply an additional 100 million doses of their COVID-19 vaccine for $1.95 billion, bringing the total number of doses to be delivered to the US to 200 million. Full delivery of both orders is expected by July 31, 2021.
• South Korea’s Hyundai Bioscience says it is working with the country’s authorities to schedule an efficacy study of its developmental injection drug, Poly-COV01, for the treatment of patients with severe cases of COVID-19 who cannot ingest drugs orally or through nasal inhalation.
• CDMO Catalent will provide support for chemistry, manufacturing and control activities and development of Novan’s intranasal formulation of berdazimer sodium for use in its coronavirus (COVID-19) program. Novan initiated in vitro assessments of its Nitricil platform against the coronavirus, targeting the reduction of viral burden in differentiated normal human bronchial epithelial cells. Results from the in vitro assessment of concentrations as low as 0.75 mg/mL demonstrated that berdazimer sodium reduced 90% of the virus after repeat dosing, once daily.
• BioNTech CEO Ugur Sahin tells a news conference that it is “highly likely” that its mRNA vaccine, BNT162, now also known as Comirnity, will be effective against a new, more contagious strain of the coronavirus circulating in the south of the UK. “We don’t know at the moment if our vaccine is also able to provide protection against this new variant. But scientifically, it is highly likely that the immune response by this vaccine also can deal with the new virus variants,” he says.
• CureVac says it has started a Phase III study with its COVID-19 vaccine, CVnCoV, in healthcare workers at the University Medical Center Mainz. The study aims to evaluate the safety and immunogenicity of CVnCoV administered as a two-dose schedule of 12 µg.
• The European Commission formally approves Pfizer and BioNTech’s vaccine against COVID-19. The two companies say they are ready to immediately ship initial doses to the 27 EU member states.
• The European Medicines Agency’s human medicines committee (CHMP) issues a positive opinion to recommend a conditional marketing authorization for the Pfizer-BioNTech COVID-19 vaccine, BNT162b2.
• Beckman Coulter announces the launch of the Access SARS-CoV-2 Antigen test, which it describes as one of the first cost-effective high-quality, high-throughput COVID-19 tests available in the US with the volume, workflow and scalable flexibility needed to help fight the pandemic. Results can be delivered in as little as 30 minutes.
• The US Food and Drug Administration approves an emergency use authorisation for Moderna’s COVID-19 vaccine, mRNA-1273.
• Belgium’s State Secretary for Budget and Consumer Protection, Eva De Bleeker, posts a tweet – since deleted – listing the negotiated prices the European Union has secured for several COVID-19 vaccines. Pfizer and BioNTech’s vaccine is priced at €12 per dose, Moderna’s at $18 per dose, and CureVac’s at €10 per dose. The cheapest vaccine on the leaked list is that of AstraZeneca and Oxford University at €1.78 per dose.
• The World Health Organisation’s COVID-19 vaccine distribution scheme, COVAX, says it now has agreements in place for nearly 2 billion doses of vaccine candidates, including the signing of an advance purchase agreement with AstraZeneca for 170 million doses of the AstraZeneca/Oxford candidate, and a memorandum of understanding with Johnson & Johnson for 500 million doses of the Janssen candidate, which is currently being investigated as a single dose vaccine.
• Horizon Therapeutics says it expects a short-term disruption in its supply of eye disease treatment, Tepezza, due to US government-mandated COVID-19 vaccine production orders related to Operation Warp Speed that have “dramatically restricted” production capacity at its CDMO partner, Catalent. The company says this prioritisation has resulted in the cancellation of previously guaranteed and contracted Tepezza manufacturing slots in December. To offset the reduced slots, Horizon has accelerated plans to increase the production scale of Tepezza and anticipates that the shortage will begin at the end of December and could last through the first quarter. “The length of the Tepezza supply disruption will depend on whether future manufacturing slots are successfully completed as well as decisions by the US Food and Drug Administration regarding this increased scale manufacturing process,” Horizon says. The company expects to submit data in January from the first increased scale manufacturing lot to the FDA for review and approval.
• Pfizer refutes comments made by Secretary of Health and Human Services, Alex Azar, that there are issues in the production and distribution of the company’s COVID-19 vaccine. “Pfizer is not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed,” Pfizer says in a statement. “This week, we successfully shipped all 2.9 million doses that we were asked to ship by the US Government to the locations specified by them.” The company adds that it has “millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses.”
• The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommends that an Emergency Use Authorization for Moderna’s COVID-19 vaccine candidate, mRNA-1273 be granted, citing an efficacy rate of 94.1%. The final decision by the FDA could come by the end of the week.
• A lab technician at Sanofi’s vaccine plant in Swiftwater, Pennsylvania, brings a class action lawsuit against the company and staffing firm, Yoh Services, for allegedly failing to fulfil a promise back in April to pay workers at the facility a 15% 'hazard' wage increase for the duration of the COVID-19 pandemic. According to the lawsuit, a manager at the plant forwarded an email from Yoh Vice President, Jeff Matvienko, in November to technicians which "appeared to be replacing seven months of promised hazard pay with three future Paid Time Off days."
• Codagenix and the Serum Institute of India announce that a Phase I clinical trial of COVI-VAC, their single-dose intranasal, live attenuated vaccine against SARS-CoV-2 has started in London. The companies say that COVI-VAC may induce a more robust immune response and long-lasting cellular immunity against SARS-CoV-2 compared to other vaccines against the virus. They add that it does not require a needle and syringe, nor ultra-low temperature freezers and can be manufactured at large scale.
• China’s Fosun Pharma says it has bought 100 million initial doses of BioNTech’s BNT162 mRNA-based vaccine candidate against COVID-19 to supply mainland China in 2021, subject to regulatory approval. Initial supply will be delivered from BioNTech’s production facilities in Germany. The deal builds on the company’s strategic collaboration, announced in March 2020, to work jointly on the development and commercialization of a potential COVID-19 vaccine based on BioNTech’s mRNA technology platform. On November 24, 2020, the companies initiated a Phase II clinical trial of BNT162b2 in Jiangsu Province, China.
• The European Medicines Agency says its human medicines committee (CHMP) has brought forward a meeting to December 21 to discuss approving a conditional marketing authorisation for BioNTech and Pfizer’s mRNA COVID-19 vaccine. “Once the CHMP recommends a marketing authorisation, the European Commission will then fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States within days,” the agency adds.
• Biotech Inovio says that together with a team of scientists from The Wistar Institute, AstraZeneca, the University of Pennsylvania, and Indiana University, it has received a USD 37.6 million grant from the US Defense Advanced Research Projects Agency (DARPA) to use Inovio's DNA-encoded monoclonal antibody technology to develop anti-SARS-CoV-2-specific dMAbs which could function as both a therapeutic and preventive treatment for COVID-19.
• Moderna says certain pre-submission documents related to its COVID-19 vaccine candidate, mRNA-1273, were unlawfully accessed during a recent cyber-attack at the European Medicines Agency. “Moderna’s submission to the EMA did not include any information identifying individual study participants and, thus, there is no information at this time that any study participants have been identified in any way,” the company says, adding that it has not identified any indications of compromise of its own data or systems in conjunction with this incident.
• China’s Sinopharm will have the capacity to manufacture 1 billion doses of COVID-19 vaccines next year, according to the president of Sinopharm subsidiary, China National Biotec Group, Yang Xiaoming, Chinanews reports. The company's two inactivated vaccine candidates are currently in phase III clinical trials in 10 countries and regions, with nearly 60,000 volunteers enrolled in the programme.
• Hundreds of local vaccination services run by family doctors and their teams will open across England this week, says the country’s National Health Service. Practices in more than 100 parts of the country started taking delivery of the vaccine Monday, with some kicking off their clinics that day but the majority starting Tuesday.
• CureVac says it has started a Phase IIb/III study of its mRNA vaccine candidate, CVnCoV, against COVID-19. The HERALD trial will assess the safety and efficacy of CVnCoV in adults at a dose of 12 µg and is expected to include more than 35,000 participants at sites in Europe and Latin America.
• FedEx says that operations are in motion to transport its first shipments of Pfizer and BioNTech’s COVID-19 vaccine to dosing centres in the US. “Vaccine distribution will be balanced among major cargo carriers, and FedEx is working closely with healthcare customers to prepare for additional vaccine shipments and transportation of critical vaccine-related supplies,” the company says.
• Moderna says the US government has exercised its option to buy an additional 100 million doses of its COVID-19 vaccine, mRNA-1273, bringing its confirmed order commitment to 200 million doses. Of the first 100 million doses purchased by the US government, approximately 20 million doses will be delivered by the end of December 2020 and the balance will be delivered in the first quarter of 2021. The additional 100 million doses will be delivered in the second quarter of 2021. All deliveries are subject to an EUA being granted.
• The US Food and Drug Administration confirms it has issued the first emergency use authorization (EUA) for a COVID-19 vaccine, which will allow Pfizer and BioNTech’s shot to be distributed in the US.
• AstraZeneca says it will start a clinical trial program to assess the safety and immunogenicity of a combination of its COVID-19 vaccine candidate, AZD1222, with the Sputnik V vaccine, developed by Russia’s Gamaleya Research Institute. Both AZD1222 and Sputnik V are adenoviral vector vaccines that contain genetic material of the SARS-CoV-2 virus spike protein. In a statement, AstraZeneca says it is “working with industry partners, governments and research institutions around the world, and will soon begin exploring with Gamaleya Research Institute in Russia to understand whether two adenovirus-based vaccines can be successfully combined.”
• Pfizer and BioNTech reveal that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the agency granting Emergency Use Authorization for the companies’ COVID-19 mRNA vaccine, BNT162b2. VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study which demonstrated a vaccine efficacy rate of 95% in participants. The FDA will take the advisory committee’s recommendation into consideration when it makes a final determination. In a statement, the FDA says “it will rapidly work toward finalization and issuance of an emergency use authorization.”
• Australian company CSL announces that following consultation with the Australian government, it will not progress its UQ-CSL v451 COVID-19 vaccine candidate to Phase 2/3 clinical trials after some participants tested a false positive for HIV. CSL’s manufacture of approximately 30 million doses of the Oxford/AstraZeneca vaccine candidate, AZD1222, is underway, with first doses planned for release to Australia early next year. In addition, CSL has agreed to manufacture an additional 20 million doses.
• Moderna says the first participants have been dosed in the Phase II/III study of mRNA-1273, its vaccine candidate against COVID-19, in adolescents ages 12 to less than 18. The study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart and Moderna intends to enroll 3,000 participants.
• Health Canada grants an emergency use authorisation to Pfizer and BioNTech for their mRNA COVID-19 vaccine, BNT162b2. The distribution of the vaccine in Canada will be prioritized according to populations identified in guidance from the National Advisory Committee on Immunizations. BioNTech will hold the regulatory approval in Canada, while Pfizer Canada will have the commercialization rights.
• BioNTech says it has been informed by the European Medicines Agency that the agency has been subject to a cyber attack and that some documents stored on an EMA server relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, had been unlawfully accessed. The company adds no BioNTech or Pfizer systems have been breached in connection with the incident. “At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyber attack will have no impact on the timeline for its review,” it says.
• Roche announces a partnership with Moderna to utilise its Elecsys Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies, Roches says. Significantly, Moderna’s vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein. This follows the recent announcement that Roche has received Emergency Use Authorization from the US Food and Drug Administration for Elecsys.
• Around 110,000 doses of Pfizer and BioNTech’s COVID-19 vaccine are expected to arrive in Israel, according to the Jerusalem Post. Health Ministry director-general Chezy says vaccinations will begin on December 20.
• Results of an interim analysis of Phase III tests on AstraZeneca’s AZD1222 vaccine are published in medical journal The Lancet, demonstrating that the vaccine is 70.4% effective at preventing symptomatic COVID-19 and protects against severe disease and hospitalisation. The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University and previously announced on November 23.
• AstraZeneca signs up Dutch CDMO Halix for large-scale commercial drug substance manufacture of its adenovirus vector-based COVID-19 vaccine, AZD1222. Under the agreement, Halix will provide commercial manufacturing of drug substance at its cGMP facility at the Leiden Bio Science Park in the Netherlands.
• Serum Institute of India CEO, Adar Poonawalla, tweets that the company has applied for emergency use authorisation in India for its COVID-19 vaccine, Covishield.
• China’s Sinovac Biotech announces it has secured approximately USD 500 million in funding from Sino Biopharmaceutical for further development, capacity expansion and manufacturing of its COVID-19 vaccine candidate, CoronaVac, as well as to conduct other development and operational activities. In return, Sino Biopharmaceutical will take a 15% stake in the company. “In addition to funding the CoronaVac, this new strategic partnership…further enables us to improve our vaccine sales capabilities, expand in Asia markets, develop and access new technologies, and most importantly, accelerate our efforts to help combat the global pandemic,” says Weidong Yin, Chairman, President and CEO of Sinovac.
• China’s Clover Biopharmaceuticals says that in Phase I trials, its two protein-based COVID-19 vaccine candidates adjuvanted with either GSK’s pandemic adjuvant system or Dynavax’s CpG 1018 plus alum induced strong neutralizing immune responses in 150 adult and elderly subjects. The company says both demonstrated a favourable safety and tolerability profile and have also shown long-term stability at 2-8oC, “making them suitable for global distribution.” A global phase II/III trial of the S-Trimer vaccine candidate in combination with GSK’s pandemic adjuvant system is expected to begin in December 2020 funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
• Becton Dickinson announces plans to invest $1.2 billion over the next four years in expanding and upgrading its global pre-fillable syringe manufacturing capacity and technology and advanced drug delivery systems over the next four years, including a new production facility in Europe. The announcement comes at a time when global demand for syringes is projected to soar with COVID-19 vaccination programmes expected to start taking off in earnest in 2021.
• Biotech Inovio announces an agreement with Kaneka Eurogentec to manufacture Inovio's COVID-19 vaccine candidate, INO-4800, --currently in Phase II -- at its plasmid production scales. Terms of the agreement were not disclosed. Kaneka Eurogentec joins existing CDMO partners Thermo Fisher Scientific, Richter-Helm BioLogics and Ology Biosciences in Inovio's global manufacturing consortium.
• IBM says it has discovered a highly-targeted phishing campaign by hackers against the COVID-19 vaccine cold chain supporting the Gavi Alliance and UNICEF's efforts to safely transport a vaccine to underdeveloped regions. “This campaign has the hallmarks of a state-sponsored attack,” it says. Some of the elements detailed in IBM's research include attackers impersonating a key individual from a Chinese biomedical company to conduct spear-phishing attacks against global organizations that provide material support to the cold chain and credential harvesting attempts against organizations in at least six countries to access sensitive information pertaining to the vaccine transport and distribution.
• Interpol issues a global alert to law enforcement across its 194 member countries warning them to prepare for organized crime networks targeting COVID-19 vaccines, both physically and online. The ‘Orange Notice’ outlines potential criminal activity in relation to the falsification, theft and illegal advertising of COVID-19 and flu vaccines. “As governments are preparing to roll out vaccines, criminal organizations are planning to infiltrate or disrupt supply chains,” says Interpol Secretary General, Jürgen Stock.
• Appili Therapeutics says the first participant has been dosed in its US-based Phase III PRESECO trial evaluating oral Avigan (favipiravir) for the treatment of COVID-19. Appili has hired CRO PRA Health Sciences to administer the trial, which will enroll approximately 826 participants, at 47 outpatient sites. Appili expects to report early data in the first half of 2021.
• The UK’s Medicines & Healthcare Products Regulatory Agency grants an emergency use authorisation (EUA) for Pfizer and BioNTech’s COVID-19 mRNA vaccine, BNT162b2. Distribution of the vaccine will be prioritized according to the populations identified in guidance from the UK Joint Committee on Vaccination and Immunisation. “Today’s Emergency Use Authorization in the UK marks a historic moment in the fight against COVID-19,” says Pfizer CEO and chairman, Albert Bourla. “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world.”
• The European Medicines Agency confirms it has received an application for conditional marketing authorisation (CMA) for Pfizer and BioNTech’s COVID‑19 mRNA vaccine, BNT162b2. The agency says the assessment will proceed under an accelerated timeline and an opinion on the marketing authorisation could be issued within weeks. In addition, the agency’s human medicines committee says it has started a rolling review of Johnson & Johnson’s COVID-19 vaccine, Ad26.COV2.S, with early clinical studies suggesting that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus.
• The US Food and Drug Administration says it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on December 17 to discuss the emergency use authorization (EUA) request for Moderna’s COVID-19 vaccine, mRNA-1273.
• Three members of the COVID R&D Alliance - Amgen, Takeda Pharmaceutical and UCB – announce the first patient has enrolled in the COMMUNITY Trial (COVID-19 Multiple Agents and Modulators Unified Industry Members), a randomized, double-blind, placebo-controlled, adaptive platform studying different therapeutic candidates for hospitalized COVID-19 patients.
• Novavax says it expects its pivotal Phase III clinical trial for its COVID-19 vaccine candidate, NVX-CoV2373, in the US and Mexico to begin “in the coming weeks.” The company says it has been working with the US Food and Drug Administration to complete trial-initiation gating activities related to its commercial-scale production at CDMO Fujifilm Diosynth Biotechnologies in Research Triangle Park, North Carolina.
• The UK could become the first western country to approve a COVID-19 vaccine, reports the Financial Times. Pfizer and BioNTech’s candidate, BNT162b2, -- of which the UK has ordered 40 million doses -- could be approved this week while distribution would begin within hours of the authorisation, the newspaper says, quoting government officials.
• Moderna says it is requesting an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) for its COVID-19 vaccine, mRNA-1273.
• India’s Mumbai International Airport has assembled a COVID task force to handle the logistics of vaccines arriving by plane into the country, a spokesman tells the Times of India. “The task force will work at temperature management, reduce dwell time (the duration that cargo containers spend within temporary storage facilities in transit, like at airports) with prior special approvals from regulators in order to ensure an unbroken cold chain for vaccine movement from the manufacturing facility to the end distributor,” they say.
• Indian generics manufacturer, Hetero, agrees a deal with the Russian Direct Investment Fund to produce in India over 100 million doses annually of the Russian vaccine against coronavirus, Sputnik V. The parties intend to start production at the start of 2021.
• The Gavi vaccine alliance, coordinator of the COVAX facility, says that through a Memorandum of Understanding it signed with AstraZeneca on June 4 as well as agreements with the Bill and Melinda Gates Foundation and the Serum Institute of India, hundreds of millions of doses of the AstraZeneca/Oxford COVID-19 vaccine candidate have now been secured.
• BioNTech and Shanghai Fosun Pharmaceutical announce that their mRNA COVID-19 vaccine candidate, BNT162b2, will be evaluated in a Phase 2 clinical trial in Taizhou and Lianshui, Jiangsu Province, China. The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. Online recruitment will start with 960 healthy participants, aged between 18 and 85.
• The European Union agrees to buy up to 160 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, European Commission president Ursula von der Leyen tells Reuters. The deal increases the EU’s potential stock of COVID-19 shots to nearly 2 billion.
• Meanwhile, Swedish CDMO Recipharm signs a letter of intent with Moderna to formulate, fill and finish mRNA-1273. Recipharm will perform the activity at its drug product manufacturing facility in Monts, France.
• Médecins Sans Frontières calls on AstraZeneca to recommit to honouring its promise to not profit off its COVID-19 vaccine candidate, AZD1222, as well as make its vaccine licenses and agreements public “so the vaccine’s efficacy can be properly determined and people and governments have the information they need to demand a fair price.” AstraZeneca previously said it would not profit from the vaccine during the pandemic and has stated prices ranging from USD3-4 per dose. However, MSF claims that terms of a deal with AstraZeneca disclosed by the Financial Times show that there are limits to the public “no profit” commitments, and that the company has given itself the power to declare the pandemic over as soon as July 2021.
• Russia’s Sputnik V COVID-19 vaccine demonstrated a 91.4% efficacy rate during the second interim data analysis of Phase III clinical trials, according to the Gamaleya Research Institute and the Russian Direct Investment Fund, the country’s sovereign wealth fund. Evaluation of efficacy was carried out among 18,794 volunteers, 28 days after receiving the first dose (7 days after the second dose) of the vaccine or placebo upon reaching the second check point of the trial.
• Biotech CureVac signs a deal with chemical firm Wacker Chemie AG for the manufacturing of CureVac’s mRNA COVID-19 vaccine candidate, CVnCoV. Under the terms of the initial agreement, Wacker will ramp up GMP production CoV at its biotech site in Amsterdam in the first half of 2021 for a planned annual production of more than 100 million doses. Preparations for the start of production, technology transfers and test runs are already underway.
• Merck & Co agrees to buy privately held biopharma company OncoImmune for an upfront payment of USD 425 million in cash. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase III study evaluating its lead therapeutic candidate CD24Fc for the treatment of patients with severe and critical COVID-19.
• AstraZeneca says interim analysis of clinical trials of its COVID-19 vaccine candidate, AZD1222, in the UK and Brazil show the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis. One dosing regimen of 2,741 participants showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen of 8,895 participants showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%.
• Regeneron announces its antibody cocktail therapy for COVID-19 has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Casirivimab and imdevimab administered together has been authorized for the treatment of mild to moderate COVID-19 in adults, as well as in paediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.
• AbCellera announces that Health Canada has approved bamlanivimab (LY-CoV555) 700 mg, its human antibody developed in collaboration with Eli Lilly, for use against COVID-19. Bamlanivimab, which has been shown in clinical trials to reduce viral load, symptoms, and hospitalizations, has been authorized for the treatment of adults and paediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and who are at high risk of progressing to severe COVID-19 illness and/or hospitalization.
• ApiJect Systems announces it has been granted a USD590 million loan by the US International Development Finance Corporation which will significantly expand its fill-finish capacity for injectable medicines and vaccines, beginning with those for COVID-19. The company will build a 1 million sq ft multi-facility campus at Research Triangle Park, North Carolina, home to the ApiJect Gigafactory, with an annual capacity of 3 billion single-dose prefilled injectors.
• The US Food and Drug Administration issues an Emergency Use Authorization for the distribution and emergency use of Eli Lilly’s baricitinib in combination with Gilead’s remdesivir in hospitalized COVID-19 patients who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
• However, the World Health Organisation issues a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, saying there is currently no evidence that the drug improves survival and other outcomes in these patients. The recommendation was developed by an international guideline development group, which includes 28 clinical care experts, four patient-partners and one ethicist.
Gilead counters that remdesivir (brand name Veklury) is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous national organizations, including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany, based on evidence from studies published in peer-reviewed journals. “We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries,” the firm says.
• BioNTech CEO Ugur Sahin tells CNN that the company and its COVID-19 vaccine development partner, Pfizer, will file for an Emergency Use Authorisation from the FDA on 21 November. “Our goal is to supply several hundred million of doses in the first four to five months of 2021 and this is will already have an impact in the control of COVID-19,” he says. Sahin also says the partners are working on formulation that could potentially allow the vaccine, BNT162b2, to be shipped at room temperature instead of the current minus 75 degrees Celsius, which makes global distribution challenging.
• Ahead of World Trade Organization talks to consider a landmark request by India and South Africa to waive certain intellectual property (IP) during the COVID-19 pandemic, Médecins Sans Frontières calls on all governments to support the waiver. It would allow countries to choose to neither grant nor enforce patents and other IP related to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic, until global herd immunity is achieved.
• The Lancet publishes promising peer-reviewed phase II data showing AstraZeneca's and the University of Oxford’s COVID-19 vaccine candidate stoked an immune response in patients of all ages. Healthy adults over the age of 56 showed a similar immune response to younger patients, while subjects in the oldest age group, between the ages of 73 to 74, experienced milder side effects than the younger cohort.
• Roche’s arthritis drug, Actemra (tocilizumab ) reached a key efficacy endpoint among critically ill patients with severe COVID-19, compared to patients who did not receive any immune modulation treatment, according to early findings from the REMAP-CAP trial, led by Imperial College London and the Intensive Care National Audit & Research Centre in the UK and Utrecht University in Europe.
• Almost a million people in China have taken Sinopharm’s developmental COVID-19 vaccine, says Sinopharm chairman, Liu Jingzhen, in an interview posted on WeChat. The vaccine was administered to select groups of people in July including Chinese government officials, students, and workers travelling overseas. He also claims “there has not been a single case of infection after inoculation.”
• US secretary of health and human services Alex Azar says Pfizer and BioNTech’s COVID-19 could be administered to the most vulnerable groups as early as December, dependent on regulatory approval. While these groups are yet been determined, experts have recommended healthcare workers, first responders and older citizens in nursing homes and assisted-living facilities.
• CDMO Samsung Biologics says it is producing Eli Lilly’s monoclonal antibody against COVID-19, bamlanivimab, through a long-term manufacturing agreement. The companies entered into the manufacturing partnership agreement in May 2020. Samsung says that despite the global challenges of securing stable supply of raw materials amid the pandemic, it was able to manufacture and deliver an initial supply of APIs meeting GMP and regulatory expectations within 5 months of contract signing “by leveraging the full force of both companies’ collaborative efforts.”
• CureVac announces it will significantly increase its existing manufacturing capacities for its COVID-19 vaccine candidate, CVnCoV, to up to 300 million doses in 2021 and up to 600 million doses in 2022. The company says it aims to build a broad and integrated European vaccine manufacturing network with CDMO partners for each of the key manufacturing steps for CVnCoV. An additional large-scale production facility supported by the European Investment Bank at CureVac´s headquarters in Tübingen is currently in development.
• The European Commission announces that it will authorize an Advanced Purchase Agreement for CureVac´s mRNA-based COVID-19 vaccine candidate, CVnCoV. Once finalized, the contract will provide EU member states with up to 225 million doses of the vaccine with the option to buy an additional 180 million doses. CureVac will receive an upfront payment to support the advanced clinical development of CVnCoV and the current ramp-up of its manufacturing network, as well as market launch and supply preparations.
• Moderna says it intends to submit for an Emergency Use Authorization (EUA) with the FDA in the coming weeks after preliminary Phase III data revealed its COVID-19 vaccine candidate, mRNA-1273, is 94.5% effective. The COVE study enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group.
• Stella Kyriakides, European Commissioner for Health and Food Safety says on Twitter that the European Commission will be signing a vaccine supply contract with Pfizer and BioNTech for their BNT162b2 mRNA-based vaccine candidate “later this week.”
• Johnson & Johnson’s vaccine unit, Janssen, says it has started the two-dose regimen ENSEMBLE 2 Phase II trial for its COVID-19 vaccine candidate in up to 30,000 participants worldwide. The trial will run in parallel with a similar one for a single-dose shot.
• CureVac says its mRNA-based COVID-19 vaccine candidate, CVnCoV remains stable and within defined specifications for at least three months when stored at a standard refrigerator temperature of +5°C (+41°F) and up to 24 hours as a ready-to-use vaccine when stored at room temperature. “Transport and storage of vaccines requiring ultra-low temperature setups to keep them stable, has been the topic of intense discussions and concerns in terms of feasibility, added costs and wastage,” says Dr. Florian von der Mülbe, Chief Production Officer at CureVac. “This compatibility has the potential both to enable decentralized storage and to significantly facilitate large-scale vaccination efforts during the current pandemic.”
• Biotech Moderna says it has seen enough infections in a Phase III COVE study for the first interim analysis of its COVID-19 vaccine candidate, mRNA-1273. The company says it has seen a significant increase in the rate of case identification across sites in the last week and expects the first interim analysis will include substantially more than 53 cases, the targeted trigger point. The data on these cases is being prepared for submission to the Data Safety Monitoring Board.
• Médecins Sans Frontières calls on governments around the world to urgently demand transparency from pharmaceutical corporations on COVID-19 vaccine licensing agreements. The organisation cites the “worrying” terms of a deal struck between AstraZeneca and Brazilian public research body Fundação Oswaldo Cruz (Fiocruz), which were recently disclosed. “It’s critical that companies also disclose clinical trial costs and data—especially considering that taxpayers have contributed USD12 billion towards the R&D of these potential vaccines—so people know what a fair price would be for the product,” MSF said.
• Serum Institute of India says it has completed enrolment of phase III clinical trials for AstraZeneca and University of Oxford’s vaccine candidate in India.
• Pfizer and BioNTech reach an agreement to supply 200 million doses of their BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to European Union (EU) member states, with an option for the European Commission to request an additional 100 million doses. Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. Deliveries to those member states who have elected to receive the vaccine as part of the agreement are anticipated to start by the end of 2020, subject to regulatory authorization.
• Via Twitter, US President Donald Trump alleges that Pfizer held back its recently released positive data on COVID-19 vaccine candidate, BNT162b2, until after the US election, “because they didn’t have the courage to do it before.” In an interview with CNN, Pfizer CEO Albert Bourla said the company had made the announcement “when the science told us the data was available.”
• Altimmune, a clinical-stage biopharmaceutical company, enters into an agreement with Lonza for the manufacturing of AdCOVID, a next-generation, single-dose intranasal vaccine candidate for COVID-19. Dr Vyjoo Krishnan, Vice President of Product Development, Altimmune says the company is “actively focused” on expanding its network of strategic manufacturing partners to ensure commercial readiness to supply in 2021 should clinical data support this advancement.
• Pfizer and BioNTech announce that their mRNA-based vaccine candidate, BNT162b2, was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. The companies say they will apply for Emergency Use Authorization (EUA) to the US Food and Drug Administration, planned for soon after the required safety milestone is achieved, currently expected in the third week of November.
• Speaking to the New York Times, Pfizer’s head of vaccine R&D, Dr. Kathrin Jansen distances the company from the US government’s Operation Warp Speed programme, after Vice President Mike Pence said the company’s partnership with BioNTech over mRNA-based COVID-19 vaccine, BNT162b2 was “thanks to the public-private partnership forged” by President Trump. “We were never part of the Warp Speed,” Jansen tells the newspaper. “We have never taken any money from the US government, or from anyone.”
• Novavax announces that the US Food and Drug Administration has granted Fast Track Designation for NVX-CoV2373, its COVID-19 vaccine candidate. The company expects to begin its pivotal Phase 3 clinical trial in the US and Mexico by the end of November.
• US President-elect Joe Biden meets with a 12-member coronavirus advisory board led by former surgeon general, Vivek Murthy, and the former FDA commissioner, David Kessler, to discuss how to tackle rising infection rates in the country.
• The world’s largest clinical trial of treatments for patients hospitalised with COVID-19 begins. The UK’s Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial will investigate whether aspirin can reduce the risk of blood clots in patients with COVID-19. The trial is taking place in 176 hospital sites across the UK and has so far recruited over 16,000 patients.
• Novartis says a Phase III trial investigating Ilaris (canakinumab) did not meet its primary endpoint of a greater chance of patient survival without the need for invasive mechanical ventilation, or its key secondary endpoint of reduced COVID-19 mortality, compared with standard of care.
• The UK will only receive around 4 million doses of AstraZeneca's COVID-19 vaccine, AZD1222, by year-end, rather than the 30 million doses originally touted, UK Vaccine Taskforce chief Kate Bingham tells lawmakers.
• Australia secures 50 million more potential COVID-19 vaccine doses through two new agreements that will boost federal government funding of its immunisation plan to more than $3.2 billion. Of their respective vaccine candidates, Novavax will supply 40 million doses and Pfizer/BioNTech will provide 10 million, should the vaccines be proven safe and effective through advanced clinical trials.
• BD says it has agreed an order from the Dutch Ministry of Health for 9.2 million of its rapid, point-of-care, SARS-CoV-2 antigen tests for use on the BD Veritor Plus System, which detects SARS-CoV-2 in symptomatic patients in approximately 15 minutes. The first 1.2 million units will be delivered by mid-November. This is the first government contract in Europe for this test, which was CE marked to the IVD Directive (98/79/EC) in September. The Dutch Ministry of Health increased its initial order by 8 million assays to improve testing capacity. BD expects the order to be fulfilled by June 2021.
• The Coalition for Epidemic Preparedness Innovations (CEPI) says it will fund the development of Sichuan Clover Biopharmaceuticals’ protein-based S-Trimer COVID-19 vaccine candidate through a global pivotal Phase 2/3 efficacy clinical trial and to licensure in China and globally, if the vaccine is proven to be safe and effective. CEPI’s total investment in the candidate will be up to USD328 million, including previously announced commitments of USD69.5 million.
• South Africa’s Aspen Pharmacare agrees with Johnson & Johnson’s vaccine unit, Janssen, for the technical transfer and proposed commercial manufacture of its COVID-19 vaccine candidate, Ad26.COV2-S. Aspen will perform formulation, filling and secondary packaging of the vaccine for supply to Johnson & Johnson from its existing sterile facility in Port Elizabeth, South Africa. The production area set aside for the candidates has capacity to produce more than 300 million doses per annum.
• Pfizer plans to distribute its COVID-19 vaccine directly from US manufacturing facilities and warehouses to end users with the help of trusted transportation providers instead of using government-endorsed McKesson distribution centres, says Tanya Alcorn, the company’s vice president for biopharma global supply chain in a webinar organized by the US Chamber of Commerce.
• The US Department of Health and Human Services and the US Department of Defense award Hologic a $119 million contract to expand its diagnostic testing manufacturing capacity in the US for SARS-CoV-2. This investment will enable Hologic to increase its overall domestic production capacity to 13 million COVID-19 tests per month by January 2022.
• CDMO Lonza agrees with AstraZeneca to manufacture AZD7442, an experimental combination of two antibodies that could be used to prevent and treat COVID-19. AstraZeneca plans to advance the combination, currently in Phase I trials, into Phase III in the next few weeks. Lonza will manufacture drug substance for AZD7442 at its US facilities with operations expected to start in H1 2021.
• Takeda announces it will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. The effort is part of a three-way agreement among Takeda, Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW). Moderna previously announced that the 30,000 participant Phase 3 clinical trial of mRNA-1273 at the 100 µg dose level in the US is fully enrolled.
• Novartis and Molecular Partners AG announce an option and license agreement to develop, manufacture and commercialize the latter’s anti-COVID-19 DARPin program, consisting of two direct acting antiviral therapeutic candidates, MP0420 and MP0423, for the prevention and treatment of COVID-19, with the possibility of being manufactured at scale and the potential to bypass cold storage.
• Sanofi and GlaxoSmithKline sign a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines, to supply 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities.
• Boehringer Ingelheim announces the start of a Phase 2 clinical trial of BI 764198, a TRPC6 inhibitor, which may alleviate lung damage and decrease the risk or severity of acute respiratory complications in patients hospitalized for COVID-19. The aim of therapy with BI 764198 is to reduce the need for ventilator support, to improve patient recovery rate and ultimately to save lives.
• Fujifilm Diosynth Biotechnologies says it will manufacture Eli Lilly’s COVID-19 therapeutic antibody at its facility in Hillerød, Denmark, deploying capacity reserved for the COVID-19 Therapeutics Accelerator. The Therapeutics Accelerator is an initiative launched by the Gates Foundation, Wellcome, and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments. Commercial manufacturing of the Lilly antibody therapy is expected to begin in April 2021.
• CDMO Oxford Biomedica says the fourth manufacturing suite at its new Oxbox facility has been issued a certificate of GMP compliance from the UK Medicines & Healthcare products Regulatory Agency (MHRA). Both this suite and another suite approved in September will be operating at 1000L scale and at present will be dedicated to the manufacture of a COVID-19 viral vector vaccine candidate.
• Inovio announces that the US Food and Drug Administration has placed its planned Phase 2/3 trial of its COVID-19 vaccine candidate, INO-4800, on partial clinical hold pending additional questions. The company plans to respond in October, after which the FDA will have up to 30 days to notify Inovio of its decision as to whether the trial may proceed. Inovio says the action is not due to any adverse events related to its ongoing expanded Phase 1 study of INO-4800.
• Zheng Zhongwei, an official with China's National Health Commission, says China's State Council “gained the understanding and support of the WHO” for a trial plan for the emergency use of COVID-19 vaccines at the end of June. The country has been administering shots to thousands of people under the programme before the vaccines completed Phase III trials.
• Endo International says its subsidiary, Par Sterile Products, has entered into a non-exclusive agreement with Novavax to provide fill-finish manufacturing services at its plant in Rochester, Michigan for NVX-CoV2373, Novavax's COVID-19 vaccine candidate. Under the terms of the agreement, the facility has begun production of the final drug product, with initial batches to be used in Novavax's pivotal Phase 3 US clinical trial.
• The Russian Direct Investment Fund, Russia’s sovereign wealth fund, and ChemRar Group have agreed to supply Avifavir (favipiravir), Russia’s first drug approved for the treatment of COVID-19, to 17 countries. Avifavir will be delivered to Argentina, Bulgaria, Brazil, Chile, Colombia, Ecuador, El Salvador, Honduras, Kuwait, Panama, Paraguay, Saudi Arabia, Serbia, Slovakia, South Africa, UAE and Uruguay.
• Symptoms that prompted the University of Oxford and AstraZeneca to put clinical trials of their coronavirus vaccine candidate, AZD1222, on hold are unlikely to be due to the shot itself, according to a participant information sheet posted online by the university. “After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine,” the document reads. “In each of these cases, after considering the information, the independent reviewers recommended that vaccinations should continue.”
• BioNTech agrees to buy Novartis’ manufacturing facility in Marburg, Germany with a view to expanding its COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. The transaction is expected to close in the fourth quarter of 2020. The Company plans to be able to produce up to 250 million doses of the shot, BNT162b2, in the first half of 2021.
• Eli Lilly and Amgen announce a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly's potential COVID-19 therapies. Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Through this collaboration, the two companies are aiming to quickly scale up production should one or more of Lilly's antibody therapies prove successful.
• BioNTech receives a grant of up to EUR 375 million from the German Federal Ministry of Education and Research (BMBF) to support the accelerated development of SARS-CoV-2 vaccines. BioNTech will use the milestone-based BMBF funding to support its contribution to the mRNA vaccine programme, BNT162, that is being co-developed with Pfizer and Fosun Pharma respectively. The goal of the initiative is the expansion of vaccine development and manufacturing capabilities in Germany, as well as the expansion of the number of participants in late-stage clinical trials.
• The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories have agreed to cooperate on clinical trials and distribution of the Sputnik V vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, developed by Moscow's Gamaleya Research Institute, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.
• Valneva signs up Dynavax to supply its CpG 1018 adjuvant for use in Valneva's SARS-CoV-2 vaccine candidate, VLA2001. Valneva separately announces an agreement with the UK government to provide up to 190 million doses of VLA20011 over a five-year period. Dynavax will supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase up to an additional 90 million doses through 2025.
• The CEOs of nine major pharma and biotech companies -- AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck & Co, Moderna, Novavax, Pfizer and Sanofi - sign a pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.
Among the commitments are promises to continue to adhere to high scientific and ethical standards in clinical trials and manufacturing processes and to only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study.
• The World Health Organisation says it does not expect mass vaccination against COVID-19 until the middle of next year. “Phase 3 must take longer because we need to truly see how protective the vaccine is and we also need to see how safe it is,” WHO spokeswoman Margaret Harris tells a UN briefing.
• Johnson & Johnson announces that its lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, elicited an immune response by “neutralizing antibodies” and prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2. The pre-clinical data was published in Nature Medicine.
• CDMO Albany Molecular Research announces it has signed a supply agreement with AstraZeneca to support the manufacture of its COVID-19 vaccine candidate, AZD1222. The company will provide sterile fill/finish of AZD1222 at its manufacturing facility in Albuquerque, New Mexico.
• Sanofi and GlaxoSmithKline say they have started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US. The companies anticipate first results in early December 2020, which will support the initiation of a Phase 3 trial that month.
• Cell and gene-therapy focused CDMO Oxford Biomedica signs an 18-month supply agreement with AstraZeneca for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The Parties may extend the supply period by a further 18 months into 2022 and 2023 by mutual agreement. Under the terms of the agreement, AstraZeneca will pay Oxford Biomedica GBP 15 million upfront as a capacity reservation fee. Subject to satisfactory scale up of manufacturing capacity and continuation of the vaccine programme, Oxford Biomedica expects to receive additional revenue in excess of GBP 35million plus certain materials costs for the manufacture of multiple large-scale batches until the end of 2021.
• Vir Biotechnology and GlaxoSmithKline say that the first patient has been dosed in a phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalisation. Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021.
• Johnson & Johnson says it has agreed in principle to supply the Government of Canada with up to 38 million doses of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S if it is approved. The parties will negotiate a final advance purchase agreement in due course under which Canada would purchase the does on a not-for-profit basis for emergency pandemic use.
• Novavax announces it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of its COVID-19 vaccine, NVX-CoV2373. Novavax and Canada expect to finalize an advance purchase agreement under which Novavax will supply doses beginning as early as the second quarter of 2021. This purchase arrangement will be subject to licensure of the Novavax vaccine by Health Canada.
• Thermo Fisher Scientific officially cuts the ribbon on its new USD 40 million facility in Lenexa, Kansas dedicated to viral transport media (VTM) production. The company says the site will continue to expand to meet expected sustained demand for COVID-19 testing. The facility has created more than 300 new full-time jobs and added 120,000 square feet of manufacturing capacity.
• Moderna confirms it is in discussions with the Ministry of Health, Labour and Welfare of Japan to potentially purchase 40 million or more doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19. Under the terms of the arrangement, the vaccine would be supplied by Moderna and distributed in Japan by Takeda Pharmaceutical beginning in the first half of 2021, if the vaccine receives regulatory approval.
• Hong Kong-listed Jacobson Pharma signs a Letter of Intent with Fosun Industrial to market and supply potentially 10 million doses of BioNTech’s BNT162 mRNA-based COVID-19 vaccine candidate in Hong Kong and Macau.
• CDMO Ology Bioservices announces it has been awarded a contract worth up to USD 106.3 million by the US Army Contracting Command, Aberdeen Proving Ground, Maryland in which it will manage the reservation of production capacity of approximately 186,840,000 doses of critical vaccines and therapeutics for COVID-19. This work is in support of the Operation Warp Speed response to the ongoing pandemic.
• Scancell Holdings of the UK says it has secured funding from Innovate UK to start a phase 1 clinical trial of its COVID-19 vaccine in 2021. Scancell’s DNA vaccines target dendritic cells to stimulate high avidity T cells that identify and destroy diseased cells. The company is set to receive approximately GBP2 million of the consortium awarded funding and expects it to cover most of the development and Phase 1 trial costs.
• AstraZeneca dismisses reports it is in talks with the US government over a potential Emergency Use Authorisation for its COVID-19 vaccine, AZD1222. AstraZeneca “has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility,” the company says in a statement.
• Moderna says it has concluded advanced exploratory talks with the European Commission to supply 80 million doses of its COIVD-19 vaccine candidate, mRNA-1273. The potential purchase agreement provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.
• Catalent Cell & Gene Therapy says it will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland. Catalent will prepare the facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance starting late in the third quarter of 2020. The agreement expands on Catalent’s previous agreement with AZ that its facility in Anagni, Italy, will provide large-scale vial filling and packaging of AZD1222.
• The US Food and Drug Administration issues an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients. The agency says that “based on scientific evidence available, …this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.” The EUA authorizes the distribution of COVID-19 convalescent plasma in the US and its administration by health care providers to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.
• Pfizer and BioNTech reveal more positive clinical trial data for their COVID-9 vaccine candidate, BNT162b2. Across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of participants. Assuming clinical success, the companies say they are on track to seek regulatory review as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
• Oragenics signs up CDMO Avid Bioservices to provide analytical method development, process development and drug substance manufacturing services to support development of Oragenics’ novel SARS CoV-2 (COVID-19) spike protein vaccine candidate, Terra CoV-2. The firms will immediately start the initial phase of the project, which includes analytical method feasibility and qualification activities. The companies then plan to advance to upstream and downstream process development and CGMP drug substance manufacturing of Terra CoV-2 within Avid’s Myford facility.
• Germany’s CureVac says it has concluded exploratory talks with the European Commission outlining an Advanced Purchase Agreement for its potential mRNA-based COVID-19 vaccine. The envisaged contract is intended to provide all EU Member States with up to 225 million doses and an option for an additional purchase of 180 million doses, to be supplied once the vaccine has proven to be safe and effective against COVID-19. Based on the results of a Phase 1 clinical trial, CureVac plans to initiate a Phase 2b/3 clinical trial in Q4 2020.
• Daewoong Pharmaceutical signs a deal with Institut Pasteur Korea and Korea Institute of Radiological and Medical Sciences for overseas clinical trials to develop Foistar as a COVID-19 therapy. Under the agreement, Daewoong will carry out all matters related to approval, such as supplying necessary drugs, supporting permits for overseas clinical trials, and applying for emergency use approval. IPK is responsible for overseeing joint research and development of a network for overseas researchers. KIRAMS will also co-develop clinical protocols with foreign researchers and cooperate to ensure the trials go successfully. In clinical trials, camostat, the main ingredient of Foistar, has been shown to block the new coronavirus from infiltrating healthy cells by inhibiting protease (TMPRSS2) activity necessary for the entering process.
• Regeneron and Roche announce they are joining forces to develop, manufacture and distribute REGN-COV2, Regeneron's investigational antiviral antibody cocktail. REGN-COV2 could provide a treatment option for people already experiencing symptoms of COVID-19 and has the potential to prevent infection in people exposed to the virus. The collaboration is expected to increase supply of the antiviral to at least three and a half times the current capacity, with the potential for even further expansion. REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.
• Dr. Reddy’s Laboratories announces the launch of antiviral Avigan (Favipiravir) 200 mg tablets in India as a treatment for COVID-19. The launch is part of a global licensing agreement with Japan’s Fujifilm that grants Dr. Reddy’s the exclusive rights to manufacture, sell and distribute the drug in India.
• Australian Prime Minister Scott Morrison announces he has signed a deal with AstraZeneca to provide doses of its COVID-19 vaccine, AZD1222, to every citizen for free if the candidate is successful. “If the vaccine proves successful, we will manufacture and supply vaccines straight away under our own stream and make it free for 25 million Australians,” he says.
• Johnson & Johnson announces it is founding and co-leading the new CARE (Corona Accelerated R&D in Europe) consortium, a multi-partner scientific research initiative dedicated to discovering and developing urgently needed treatment options for COVID-19. “In this role, we are helping bring together Europe’s best and brightest scientific minds from 37 renowned academic institutions, research organizations and pharmaceutical companies, together with partners from the US and China,” the company says. CARE will focus on three strategic pillars to achieve therapeutic breakthroughs against SARS-CoV-2 and other coronavirus threats: drug repositioning and repurposing, small molecule discovery and virus-neutralizing antibody discovery.
• Hyderabad-based Biological E. says it has bought Akorn India, a manufacturer of specialty generic injectable medicines and also vaccines, to enhance its manufacturing capabilities and capacities to produce its vaccines and injectable medicines. BE is in the process of developing a COVID-19 vaccine and may be able to use the facilities at Akorn India Paonta Sahib Plant in Himachal Pradesh for commercial scale manufacture of the vaccine. The Akorn India plant in Paonta Sahib, Himachal Pradesh has a sterile injectable manufacturing facility with an annual capacity for about 135 million units with the potential for an immediate 30 million-unit expansion.
• Biocon chairperson Kiran Mazumdar-Shaw tweets that she has tested positive for COVID-19. “I have added to the COVID count by testing positive. Mild symptoms and I hope it stays that way,” she says.
• Johnson & Johnson confirms it has concluded exploratory talks with the European Commission to provide its COVID-19 vaccine candidate to European Union Member States, subject to regulatory approval. J&J’s vaccines unit, Janssen Pharmaceutica NV, will now enter into contract negotiations with the EC. Under the proposed agreement, the EC would buy 200 million doses of Janssen’s SARS-CoV-2 candidate, Ad26.COV2.S on behalf of EU Member States and, potentially, other countries to be defined. The EC would also have an option of an additional 200 million doses.
• AstraZeneca concludes an agreement with the European Commission to supply up to 400 million doses of its Oxford University-partnered AZD1222 COVID-19 vaccine. Building on the existing agreement with Europe’s Inclusive Vaccines Alliance spearheaded by Germany, France, Italy and the Netherlands, the new agreement gives all EU member states the option to access the vaccine in an equitable manner at no profit during the pandemic. It also allows EU member states to redirect doses to other European countries.
• Thermo Fisher Scientific pulls its USD12.5 billion offer to acquire the Netherlands’ Qiagen, which cites stronger demand for its diagnostic reagents during the coronavirus pandemic. “The magnitude and duration of the global coronavirus pandemic have proven the increasingly critical importance of molecular testing to society. QIAGEN’s business prospects have improved significantly, as shown in our performance for the first half of 2020 and the strong outlook for the rest of this year and for 2021,” says Thierry Bernard, Qiagen CEO.
• Zydus Cadila launches remdesivir under the brand name Remdac in the Indian market, priced at IDR 2,800 for a 100 mg lyophilized injection. The drug will be made available across India through the group’s distribution chain reaching out to government and private hospitals treating COVID-19 patients.
• Biotech start-up ANA Therapeutics (ANA) says the US Food and Drug Administration has cleared its investigational new drug application for ANA001 (niclosamide capsules) as a potential treatment for COVID-19, making it the first US-based company to conduct a human clinical trial to determine the efficacy of niclosamide to treat COVID-19. The trial will seek to enroll at least 400 patients with COVID-19 at 10 centres across the US, specifically in states that are experiencing surges in coronavirus cases such as Florida and Texas and expects to enroll the first patient in August.
• The Russian government announces the world’s first approval of a COVID-19 vaccine. Sputnik V was developed by Moscow's Gamaleya Research Institute. “Today’s news that [the Russian government] ‘approved’ a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad US into forcing early action on our vaccines,” tweets former FDA Commissioner Scott Gottlieb.
• Swiss biotech Molecular Partners announces the Swiss government has reserved a defined number of initial doses of the company’s anti-COVID-19 candidate, MP0420. MP0420 builds on a three-in-one DARPin architecture to enhance potency and with the potential to prevent viral escape, in addition to manufacturing process advantages.
• Pharma companies currently in the news for developing coronavirus vaccines and therapeutics have reaped hefty reputation boosts, according to early August data compiled by The Harris Poll. Gilead, Pfizer and Moderna specifically are trending positively with consumers who have seen the news about their respective treatments and vaccines, the poll taken between July 30 and August 3 found.
Pfizer was the big winner: Among people who heard about its recent deal with the U.S. government for vaccine doses, 52% said they’d developed a more favourable view of the company. For Moderna, in the wake of its recent move to phase 3 vaccine trials, 51% of those who knew the latest had a more positive view of the company. In Gilead’s case, news about its remdesivir treatment and pricing had 48% of in-the-know poll respondents reporting better impressions of the drugmaker.
• The US government puts on hold a USD 765 million loan to Eastman Kodak to support its move into manufacturing of APIs and generic drugs. “Recent allegations of wrongdoing raise serious concerns. We will not proceed any further unless these allegations are cleared,” the US International Development Finance Corporation says in a tweet.
• Gilead Sciences says it has submitted a New Drug Application to the US Food and Drug Administration for its antiviral Veklury (remdesivir), for the treatment of patients with COVID-19. The drug is currently available in the US under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19. The firm says the filing is supported by data from Phase 3 clinical studies of Veklury conducted by Gilead and the National Institute of Allergy and Infectious Diseases.
• Pfizer says it has signed a multi-year agreement with Gilead Sciences to manufacture and supply Gilead’s antiviral remdesivir to help scale up supply of the investigational treatment for COVID-19. Under the terms of the agreement, Pfizer will provide contract manufacturing services at its McPherson, Kansas facility to manufacture and supply remdesivir for Gilead.
• Gilead says it has made process improvements that have shortened remdesivir’s manufacturing timeline to six months and expanded its global network of both internal manufacturing sites and external organizations to more than 40 companies in North America, Europe and Asia.
• Novavax partners up with Takeda for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax’s COVID‑19 vaccine candidate, in Japan. Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine annually.
• AstraZeneca says it has signed a cooperation framework agreement with BioKangtai to actively promote the development, production, supply and commercialization of its COVID-19 vaccine, AZD1222 in the China. Under the terms of the deal, BioKangtai, as the technology transferee, will provide annual production capacity of at least 100 million doses by the end of 2020, expanding to at least 200 million doses by the end of 2021.
• Johnson & Johnson announces its vaccine unit Janssen has entered into an agreement worth over USD 1 billion with the US government for the large scale domestic manufacturing and delivery of 100 million doses of its SARS-CoV-2 investigational vaccine, Ad26.COV2.S, following approval or Emergency Use Authorization. The government may purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement.
• Pfizer and BioNTech secure an agreement with the Canadian government to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and Health Canada approval. Financial details of the agreement have not been disclosed, but the terms were based on the timing of delivery and the volume of doses. Deliveries of the vaccine candidate are planned for over the course of 2021.
• BioNTech and Shanghai Fosun Pharmaceutical say that the first 72 participants have already been dosed with their COVID-19, BNT162b1, following IND approval by Chinese regulatory authority, National Medical Products Administration. BioNTech and Fosun Pharma are jointly developing the COVID-19 vaccine candidate in China. The randomized, placebo-controlled, observer-blinded Phase 1 clinical trial in China will enroll 144 healthy subjects to evaluate the safety and immunogenicity of the vaccine as well as to confirm dose selection.
• India’s Zydus Cadila says its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D, was found to be safe and well tolerated in a Phase I clinical trial. The company will start Phase II clinical trials from August 6, 2020.
• India’s Sun Pharmaceutical announces it has launched its generic version of anti-flu drug, Favipiravir, at INR 35 per tablet, for the treatment of mild to moderate cases of COVID-19 in India.
• In a blog, US Food and Drug Administration commissioner Stephen Hahn says the US pharmaceutical industry needs to make more use of advanced manufacturing technology such as continuous manufacturing and 3D printing. “Furthermore, digital and smart design and manufacturing processes also promise to increase efficiency and reduce uncertainty,” he writes.
• In an opinion piece in the Washington Post, four former US Food and Drug Administration commissioners argue that the US should push ahead with clinical trials of blood plasma collected from recovered COVID-19 patients. “The United States could desperately use such a treatment. The nation continues to struggle with high rates of hospitalizations and tragic deaths. While vaccine development continues, it’s important to advance every promising treatment option to improve the odds for those who become sick,” write Mark McClellan, Margaret Hamburg, Robert Califf and Scott Gottlieb.
• Patients admitted with COVID-19 at select hospitals may now volunteer to enroll in a clinical trial to test the safety and efficacy of a potential new treatment for the disease, says the National Institutes of Health. The Phase 3 randomized, controlled trial is known as ACTIV-3, and as a “master protocol,” it is designed to expand to test multiple different kinds of monoclonal antibody treatments. The ACTIV-3 study will begin by studying Eli Lilly’s investigational monoclonal antibody LY-CoV555, which was identified in a blood sample from a recovered COVID-19 patient.
• The US National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative awards contracts to seven companies to support a range of new lab-based and point-of-care tests for coronavirus it says could significantly increase the number, type and availability of tests by millions per week as early as September 2020. The companies supplying point-of-care tests are Mesa Biotech, Quidel and Talis Biomedical, while those providing lab tests are Ginkgo Bioworks, Helix OpCo, Fluidigm and Mammoth Biosciences. All will receive support for manufacturing and scale up.
• India’s Wockhardt says it has come to an agreement with the UK government to supply millions of doses of multiple COVID-19 vaccines to the country, including AstraZeneca and Oxford University’s COVID-19 vaccine candidate, AZD1222. Wockhardt has reserved fill-and-finish capacity - the final manufacturing step of putting vaccines into vials or syringes and packaging them - as part of the agreement.
• Sanofi and GlaxoSmithKline say they have secured funding of up to USD 2.1 billion from the US government to accelerate the development and manufacturing of their COVID-19 recombinant protein-based vaccine. More than half of the money will support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine.
The two companies say they are also in advanced discussions with the European Commission for the supply of up to 300 million doses of the COVID-19 vaccine. The doses would be manufactured in European countries including France, Belgium, Germany and Italy.
• Pfizer and BioNTech announce they have agreed with the Japanese health ministry to supply the country with 120 million doses of their mRNA-based vaccine candidate against SARS-CoV2, BNT162, subject to clinical success and regulatory approval, beginning in 2021. Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses.
• Johnson & Johnson says that pre-clinical study data published in Nature show its vector-based vaccine against COVID-19 elicited a robust immune response and successfully prevented subsequent infection from the virus in non-human primates (NHPs). Based on the strength of the data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now started in the US and Belgium.
• Sorrento Therapeutics, says that through a licensing deal with Columbia University it has secured the rights to a rapid, one-step diagnostic test that detects SARS-CoV-2 virus in as little as 30 minutes from a sample of saliva. The test developed by Columbia's team, to be marketed by Sorrento as COVI-TRACE, holds all of the testing materials in a single tube and requires no specialized laboratory equipment, making it easily deployable for point of care, on-site or potentially at-home testing.
• ExeVir Bio, a spin out of Belgium-based life sciences research institute, VIB, announces it has secured EUR 23 million of funding for its llama-derived antibody (VHH) technology platform to generate robust antiviral therapies providing broad protection against coronaviruses. Lead asset VHH72-Fc binds to a unique epitope that is conserved in SARS-CoV-1 and SARS-CoV-2 viruses and this binding prevents these viruses from entering the cell. The financing is led by Fund+, with the participation of VIB, UCB Ventures, the Belgian Federal Government via SFPI-FPIM, V-Bio Ventures and several Belgian family offices.
• The European Commission agrees a supply deal with Gilead for its antiviral, remdesivir, worth EUR 63 million. The supply will ensure the treatment of approximately 30,000 patients presenting severe COVID-19 symptoms. “This will help to cover the current needs over the next few months, while ensuring a fair distribution at EU level,” the Commission says.
• The UK government agrees a deal with Sanofi and GlaxoSmithKline, for the supply of up to 60 million doses of their COVID-19 vaccine. The companies expect a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, regulatory approval could be achieved by the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.
• In an earnings call, Pfizer CEO Albert Bourla says developed nations can expect no discount on the USD 19.50 per dose price recently agreed in the US for advance purchases of its mRNA COVID-19 vaccine.
• The Canadian health ministry grants conditional approval for Gilead’s antiviral, remdesivir (Veklury), for the treatment of patients with severe symptoms of COVID-19 who have pneumonia and require extra oxygen to help them breathe. Remdesivir is the first drug that Health Canada has authorized for the treatment of COVID-19. It will only be used in healthcare facilities where patients can be closely monitored.
• Pfizer and BioNTech say they have chosen to advance their COVID-19 vaccine candidate BNT162b2 into a 30,000 participant Phase 2/3 study, at a 30 µg dose level in a 2 dose regimen. BNT162b2, which recently received US Food and Drug Administration (FDA) Fast Track designation, encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies.
• CDMO Fujifilm Diosynth Biotechnologies says its College Station, Texas, site will support COVID-19 vaccine candidate manufacturing as part of Operation Warp Speed, a US government program that aims to begin delivering millions of doses of a vaccine to the US population. The Biomedical Advanced Research and Development Authority has issued a task order reserving the flexible biomanufacturing facility until the end of 2021.
• CDMO Emergent BioSolutions announces it has signed an agreement for large-scale commercial drug substance manufacturing for AstraZeneca’s and the University of Oxford’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately USD 174 million through 2021 and follows a USD 87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.
• The Biomedical Advanced Research and Development Authority says it had modified its existing contract with Moderna to the tune of USD 472 million to support the biotech’s late stage clinical development including an expanded 30,000 participant Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19. An earlier award from BARDA for up to USD 483 million was made to support the scale up of mRNA-1273 and clinical development, originally with a smaller anticipated number of participants in the Phase 3 clinical trial.
• Moderna announces that the Phase 3 study of its mRNA vaccine candidate, mRNA-1273, against COVID-19 has begun dosing participants. The COVE (Coronavirus Efficacy) study, is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
• The US Food and Drug Administration approves LabCorp's coronavirus diagnostic for use in people without COVID-19 symptoms. “FDA’s authorization of the first diagnostic test to be used for anyone, regardless of whether they are showing symptoms of COVID-19 or have other exposure risk factors, is a step toward the type of broad screening that may help enable the reopening of schools and workplaces,” says FDA Commissioner Stephen Hahn.
• Biotech Immunic Therapeutics says enrolment of the first patients has begun in a phase 2 clinical trial of its selective oral DHODH inhibitor, IMU-838, for the treatment of patients with coronavirus disease 2019 (COVID-19). The IONIC will evaluate efficacy and safety of IMU-838 in combination with the neuraminidase inhibitor, oseltamivir (Tamiflu), in approximately 120 adult patients with moderate-to-severe COVID-19.
• In a letter to major pharmaceutical firms developing potential vaccines against COVID-19, the US Department of Justice says it will not impede sharing of information by companies to share information to scale up capacity to manufacture antibody treatments. “Waiting until regulators approve specific treatments before scaling up manufacturing might delay access to these potentially life-saving medicines by many months,” the DoJ says.
• Biotech Novavax has signed up CDMO Fujifilm Diosynth Biotechnologies to manufacture bulk drug substance for its COVID-19 vaccine candidate, NVX-CoV2373. FDB's site in Morrisville, North Carolina has begun production of the first batch. Novavax is aiming to deliver 100 million doses from the end of 2020 and the batches being produced at the FDB site will be utilized in a future Phase 3 clinical trial of up to 30,000 subjects expected to begin in the autumn of 2020.
• The UK government says it is investing an additional GBP 100 million in a Cell and Gene Therapy Catapult Manufacturing Innovation Centre to accelerate the mass production of a successful COVID-19 vaccine in the UK. Due to open in December 2021, the centre will have the capacity to produce millions of doses each month providing the UK with the capabilities to manufacture future vaccines, including for emerging diseases.
• The European Medicines Agency says it has set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. This is underpinned by three contracts for observational research that the agency has signed with academic and private partners.
In May, the agency commissioned the ACCESS project (‘vACcine Covid-19 monitoring readinESS’) for preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice, once authorised.
In June, EMA contracted IQVIA to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients.
And most recently, the agency signed a contract with Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’). This project will collect data on the impact of COVID-19 in pregnancy in order to guide decision-making about vaccine indications, vaccination policies and treatment options for COVID-19 in pregnant women.
• Pfizer and BioNTech SE announce a USD1.95 billion agreement with the US Department of Health and Human Services and the Department of Defense to begin delivering 100 million doses of their vaccine for COVID-19, BNT162. Under the agreement, the US government will receive 100 million doses of the shot, after Pfizer successfully manufactures and obtains approval or emergency use authorization from the US Food and Drug Administration. The government has an option to buy a further 500 million doses.
• Japan’s health ministry approves the steroid dexamethasone as a second treatment of COVID-19 after a trial in the UK showed the drug reduced death rates in hospitalised patients. The ministry has included dexamethasone as an option for treatment along with Gilead’s antiviral drug remdesivir.
• South Korea's SK Bioscience signs a manufacturing deal with AstraZeneca which will see it manufacture doses of the UK firm’s COVID-19 vaccine candidate, AZD1222. SK Bioscience will start producing undiluted solutions of the vaccine after discussing production plans with AstraZeneca. The manufacturing contract will last until early next year and could be extended if the vaccine is successful.
• The Egyptian health ministry says China has selected Egypt as a future manufacturing hub for a coronavirus vaccine in Africa once it has been developed. Egyptian health minister Hala Zayed met with Chinese Ambassador Liao Liqiang to discuss Egypt’s participation in the testing of coronavirus vaccines in cooperation with a Chinese firm. The meeting discussed cooperation between the health ministry’s national vaccination centre, VACSERA, and a Chinese company carrying out vaccine trials.
• Italian CRO IRBM agrees a new research collaboration agreement with Merck & Co to identify and develop novel peptide therapeutics active against different strains of coronavirus, including SARS-CoV-2. The parties will collaborate in hit to lead optimization and preclinical drug development to rapidly advance selected candidates towards the clinic.
• Pfizer and BioNTech come to an agreement with the UK to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development, subject to regulatory approval. Financial details of the agreement were not disclosed, but the terms are based on the timing of delivery and the volume of doses.
• Mylan announces the commercial launch in India of its version of Gilead’s antiviral remdesivir, under the brand name Desrem for the treatment of COVID-19. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalised with severe presentations of the disease, the company says, adding that it has launched a 24/7 helpline where patients and healthcare practitioners can access information about the drug and its availability.
• India's Drugs Controller General of India seeks a clarification from Glenmark Pharmaceuticals over alleged "false claims" about the use of anti-viral FabiFlu (favipiravir)on COVID-19 patients with comorbidities and also the pricing of the drug, after receiving a complaint from a member of Parliament. In a letter to the company, the DCGI says it has received a representation from an MP that the total cost of the treatment with FabiFlu will be around Rs 12,500 and that the "cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class and middle-class people of India."
• Novartis announces that its generics unit Sandoz will make medicines from its COVID-19 portfolio available to government, NGOs and other institutional customers in up to 79 eligible countries at zero-profit to support financially-strained healthcare systems. The portfolio includes 15 medicines for gastro-intestinal illness, acute respiratory symptoms, pneumonia as well as septic shock. The medicines were chosen based on clinical relevance and availability to ensure demand can be met globally.
• India’s Zydus Cadilla says that the first human dosing of its plasmid DNA vaccine for COVID-19, ZyCoV-D, has begun. The adaptive Phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine.
• China's AIM Vaccines is investing CNY 550 million (USD79 million) in the construction of a manufacturing and R&D facility for its COVID-19 vaccines, which it hopes to launch next March with production slated to start in the first half of 2021. Its subsidiary Rongan Biological will produce inactivated vaccines at the new plant.
• India’s Lupin shuts down one of its manufacturing plants in western Gujarat after at least 18 employees at the site tested positive for COVID-19, government officials tell Reuters.
• On an investor conference call, Moderna CEO Stéphane Bancel says the company has already started to make commercial product at risk for its COVID-19 vaccine candidate, mRNA-1273. The company and its partners Lonza and Catalent are working to produce millions of doses at three sites for the US market, he adds.
• IQVIA and AstraZeneca announce they have teamed up to accelerate development of the latter’s potential new COVID-19 vaccine, AZD1222. This joint initiative is part of the U.S. government’s recently announced Operation Warp Speed project. The collaboration will drive faster delivery of clinical studies of the vaccine in the US and includes an expansive subject study, which is expected to begin enrolling participants this summer and will leverage IQVIA’s Virtual Trial solutions including Study Hub.
• Merck KGaA’s manufacturing services unit could earn the company billions of dollars in revenue through assisting certain firms with COVID-19 vaccine scale-up, Jefferies analyst Brandon Couillard says in a note to investors. The German company is currently working with more than 200 groups developing COVID-19 vaccines and drugs, including the UK’s Oxford University and Baylor University and Oxford University in the US state of Texas. Couillard said his team quantifies the overall market opportunity for COVID-19 products at around USD4-5 billion.
• Shanghai Fosun Pharmaceutical announces that a trial application for clinical trials of its novel coronavirus vaccine candidate, BNT162b1, in collaboration with Germany’s BioNTech has been accepted by China’s National Medical Products Administration.
• Despite pharma manufacturing being exempted from lockdown measures in India, the movement of materials appears still to be limited, the workforce to carry out manufacturing is reduced and pharma employees are restricted from travelling into work across multiple Indian states, according to GlobalData research. Widespread reduction of manufacturing capacity in India will severely disrupt the global and domestic supply chain, particularly for active pharmaceutical ingredients (APIs), GlobalData says.
• The US Food and Drug Administration says it is aiming at restarting on-site inspections in the US during the week of July 20. The agency says resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. “Our ability to resume is also affected by other services that have been curtailed by the pandemic, such as public transportation,” it says, adding that for the foreseeable future, prioritized domestic inspections will be pre-announced.
• Swiss CDMO Lonza says it has licensed its GS Xceed Expression System to Junshi Biosciences for the Chinese firm’s SARS-CoV-2 neutralizing antibody, JS016. The first healthy volunteer has been dosed in a Phase I clinical study of JS016 at Huashan Hospital affiliated to Fudan University in China in June.
• Pfizer and BioNTech announce that two of their four investigational vaccine candidates from their BNT162 mRNA-based vaccine program have received Fast Track designation from the US Food and Drug Administration. BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the program currently being evaluated in ongoing Phase 1/2 clinical studies in the US and Germany.
• India’s Biocon says it has received the Drugs Controller General of India’s (DCGI) approval to market its drug Itolizumab for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome patients due to COVID-19. Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.
• India’s Glenmark Pharmaceuticals says it has been able to reduce the price of its Avigan generic FabiFlu to INR 75 (USD0.99) per tablet for emergency use in mild-to-moderate COVID-19 patients. “The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API and formulations are made at Glenmark’s facilities in India,” the company says.
• Oragenics says that after a phase 2 trial revealed an overall lack of efficacy, it has decided to discontinue development of its candidate AG013 as a treatment of severe oral mucositis in cancer patients and instead focus on its recently acquired COVID-19 vaccine candidate, TerraCoV2.
• COVID-19 patients given Fujifilm’s drug Avigan early on in a clinical trial showed more improvement than those given delayed doses but the results did not reach statistical significance, say researchers at Japan’s Fujita Health University.
• Moderna signs up Laboratorios Farmacéuticos Rovi for large-scale, commercial fill-finish manufacturing of its COVID-19 vaccine candidate, mRNA-1273, at ROVI’s facility in Madrid, Spain. As part of the agreement, Rovi will provide vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection and labelling to support production of hundreds of millions of doses intended to supply non-US markets starting in early 2021.
• R-Pharm says its new antiviral drug, Coronavir, has been approved in Russia to treat COVID-19 patients. The company says that in a clinical trial involving mild or medium-level cases, the drug has shown to be highly effective in inhibiting replication of the new coronavirus. “Coronavir is one of the first drugs in Russia and in the world that does not tackle the complications caused by SARS-CoV-2, but battles the virus itself,” R-Pharm says.
• India’s Cipla announces it has launched its generic version of antiviral remdesivir (Cipremi) at INR 4,000 (USD53.31) per vial. “We are proud to commercially launch Cipremi today, amongst the lowest priced globally, and aim to supply over 80,000 vials within the first month itself,” says executive vice-president and CEO of Cipla’s Indian unit, Nikhil Chopra.
• The healthcare and pharma response to COVID-19 has resulted in a reputational lift for the industry among technology professionals, according to a poll commissioned by Novartis. Of those surveyed, 73% said their opinions have improved due to the sector’s reaction to the pandemic. And 72% reported they think that the industry has been effective in tackling the pandemic, while 85% believed that the application of data science has been a crucial factor in the sector’s response to it.
• Germany’s CureVac has secured a Eur75 million loan from the European Investment Bank (EIB) to support its development of vaccines against infectious diseases, including its vaccine candidate CVnCoV aimed at preventing SARS-CoV-2 infections. The loan will also support CureVac’s efforts to expand its existing GMP production capabilities and accelerate the completion of its fourth production site in Tübingen, Germany.
• Regeneron Pharmaceuticals is awarded a USD450 million contract from the US Biomedical Advanced Research and Development Authority (BARDA) to manufacture and supply its double antibody cocktail for the treatment and prevention of COVID-19, REGN-COV2.
• Biotech Novavax says it has been selected to participate in the US government program, Operation Warp Speed, to deliver a vaccine for COVID-19 in 2021. Novavax has been awarded USD1.6 billion by the federal government to complete late-stage clinical development, including a Phase 3 clinical trial; establish large-scale manufacturing and deliver 100 million doses of its vaccine candidate, NVX‑CoV2373, as early as late 2020.
• The US Food and Drug Administration issues an Emergency Use Authorization (EUA) for Becton Dickinson’s COVID-19 antigen diagnostic test, the BD Veritor System for Rapid Detection of SARS-CoV-2. The test can be used in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Emergency use of the test is limited to authorized laboratories using the BD Veritor Plus Analyzer Instrument.
• CDMO Emergent BioSolutions announces it has signed a five-year agreement for large-scale drug substance manufacturing for Johnson & Johnson’s lead COVID-19 vaccine candidate, Ad26.COV2-S. The deal, which will begin in 2021, is valued at around USD480 million for the first two years. For the remaining three years beginning in 2023, Emergent will provide a flexible capacity deployment model to support annual dose requirements.
• Regeneron Pharmaceuticals says its investigational double antibody cocktail for the treatment and prevention of COVID-19, REGN-COV2, is to enter a Phase 3 trial to evaluate its ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient. Th trial is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized patients with COVID-19.
• Mylan says that the Drug Controller General of India has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of an accelerated approval process to address urgent, unmet needs amid the evolving COVID-19 pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The drug will be launched under the brand name Desrem in India and will be available to patients in July at a price of INR 4,800, more than 80% cheaper than the branded version price available to governments in the developed world.
• The UK government is close to sealing a GBP500 million ($625 million) deal with GlaxoSmithKline and Sanofi to buy 60 million doses of their COVID-19 vaccine candidate should it gain regulatory approval, according to The Sunday Times.
• India’s Zydus Cadila says it has received approval from Mexican regulator, COFEPRIS, for its one of its lead research candidates, Desidustat, to enter a Phase 2b trial in the management of COVID-19. Clinical and regulatory development of Desidustat in COVID-19 is being executed in Mexico by CRO Avant Santé Research Center.
• The World Health Organisation says it has discontinued trial arms studying hydroxychloroquine and lopinavir/ritonavir after interim trial results showed that both drugs produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.
• Gilead Sciences announces that the European Commission has granted conditional marketing authorization for its antiviral remdesivir as a treatment for SARS-CoV-2 infection. Under this authorization, remdesivir is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.
• Tesla CEO Elon Musk tweets that the company is building mobile molecular printers to assist in the production of CureVac’s mRNA vaccine, currently in development. The machines are being designed to ship to remote locations and produce the vaccine on-site.
• Japan’s Fujifilm partners with Dr. Reddy's Laboratories and Global Response Aid for the development, manufacture and sales of flu treatment Avigan (favipiravir), a potential treatment for COVID-19. Under the agreement, Fujifilm Toyama Chemical will grant Dr. Reddy's and GRA the exclusive right to develop, manufacture and sell the drug overseas, and, receive a lump-sum license fee and royalties on sales.
• The Trump administration says it has bought more than 500,000 doses of Gilead’s of antiviral remdesivir, which constitutes the company’s entire production for July and 90% of August and September. “President Trump has struck an amazing deal to ensure Americans have access to the first authorised therapeutic for Covid-19,” says US Health and Human Services secretary, Alex Azar.
• GlobalData analysis shows that Q1 2020 global sales for companies that were not developing a COVID-19 drug saw an 8% increase when compared to the archived global sales forecast for the same time period. In contrast, companies that were developing a COVID-19 drug only saw a 3% increase. “Companies with fewer marketed drugs that are relying predominantly on the COVID-19 asset in their pipeline are gambling a lot on the drug going to market, whereas other big Bio/Pharma companies may win in the long-term due to their diverse portfolios of drugs,” says analyst Madeleine Roche.
• AstraZeneca confirms it has agreed a USD127 million deal with the Brazilian government to manufacture doses of the University of Oxford's adenovirus-based COVID-19 vaccine candidate, AZD1222. Brazil has committed to make 30 million finished doses available, half of which should be available by December. Brazil has also committed to manufacture an additional 70 million doses, with AstraZeneca supplying the vaccine at no cost.
• Gilead Sciences’ CEO Daniel O’Day announces that the company has set a price for its antiviral remdesivir for governments of developed countries at USD390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to USD2,340 per patient.
• Beckman Coulter announces that its Access SARS-CoV-2 IgG antibody test has received Emergency Use Authorization from the US Food and Drug Administration. The company has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the US and has begun distribution of the test globally to countries that accept the FDA EUA and CE Mark. The company says it is able to deliver more than 30 million tests a month.
• China’s CanSino Biologics says use of its COVID-19 vaccine candidate by the country’s military for a period of one year from June 25 has been approved by the Central Military Commission. “The Ad5-nCoV is currently limited to military use only and its use cannot be expanded to a broader vaccination range without the approval of the Logistics Support Department,” CanSino says.
• Japan’s Daiichi Sankyo says it is continuing discussions with AstraZeneca for the stable supply in Japan of AZD1222, a potential COVID-19 vaccine that the Anglo-Swedish firm is developing in partnership with Oxford University. AstraZeneca has agreed to advance specific discussions with the Japanese government toward the introduction of the vaccine in Japan, and based on that agreement, Daiichi Sankyo has decided to advance discussions with AstraZeneca to formulate the vaccine, including vial filling, packaging, and storage in Japan.
• Merck KGaA says it has received US Food and Drug Administration clearance to take its investigational drug, M5049, for the treatment of patients with COVID-19 pneumonia. M5049 is a potentially first-in-class small molecule that blocks the activation of Toll-like receptor (TLR)7 and TLR8, two innate immune sensors that detect single-stranded RNA from viruses such as SARS-CoV-2, the virus responsible for COVID-19.
• Moderna hires Catalent for large-scale, commercial fill-finish manufacturing of its mRNA-based COVID-19 vaccine candidate (mRNA-1273) at the CDMO’s biologics facility in Bloomington, Indiana. Under the agreement, Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24x7 manufacturing operations to support production of an initial 100 million doses intended to supply the US market starting in Q3 2020.
• The European Medicines Agency’s human medicines committee (CHMP) recommends granting a conditional marketing authorisation to remdesivir for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU.
• Vizient, shares data showing a 610% increase in demand by its member US hospitals for corticosteroid, dexamethasone, in the week since the initial trial results of a UK clinical study showed it reduced the mortality of patients who are severely ill with COVID-19. As a result of the spike in demand, fill rates for the products have fallen from 97% to 54% for Vizient member hospitals.
• The UK government says testing for coronavirus infection could become quicker, more convenient and more accurate, following the launch of a multicentre national programme to evaluate how new diagnostic tests perform in different health and care settings. The COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) - funded by the National Institute for Health Research, UK Research and Innovation, Asthma UK and the British Lung Foundation - will create a single national route for evaluating new diagnostic tests in hospitals and in community healthcare settings.
• The US Institute for Clinical and Economic Review (ICER) releases updated analyses to inform public debate of pricing for Gilead’s antiviral remdesivir and other future treatments of COVID-19. In ICER’s updated base case analysis, the highlighted cost-effectiveness benchmark price range for remdesivir is marked at USD4,580 to USD5,080 per treatment course. However, should dexamethasone’s benefits to severely ill COVID-19 patients be confirmed, the same cost-effectiveness price benchmark for remdesivir falls to a range of USD2,520 to USD2,800.
• Symbiosis Pharmaceutical Services, says it has signed a supply agreement with AstraZeneca for sterile clinical manufacture of the Anglo-Swedish pharma company’s COVID-19 vaccine, AZD1222.
• In a regulatory filing to the Bombay Stock Exchange, Ipca Laboratories says the US Food and Drug Administration has reinstated an import alert on its hydroxychloroquine sulphate and chloroquine phosphate APls and hydroxychloroquine sulphate tablets – which was lifted in March -- due to shortages of the drug being resolved.
• Sanofi Pasteur, Sanofi’s vaccines unit, and Translate Bio a clinical-stage messenger RNA (mRNA) therapeutics company, have agreed to further expand their existing 2018 collaboration and license agreement to develop mRNA vaccines. Under the expansion agreement, Translate Bio will receive an upfront payment of USD425 million, consisting of a USD300 million cash payment and a private placement common stock investment of USD125 million.
• Inovio Pharmaceuticals announces it has received USD71 million funding from the US Department of Defense to support the large-scale manufacture of its Cellectra smart devices, which are used to deliver its COVID-19 vaccine, INO-4800, directly into the skin.
• The Pirbright Institute, working in collaboration with the University of Oxford announce results showing that two doses of AstraZeneca’s COVID-19 shot, AZD1222, produce a greater antibody response than a single dose in pigs. Phase 1 human clinical trials of the single dose vaccine have already begun following research that showed that macaques were protected against lung disease after a single immunisation.
• CDMO Piramal Pharma Solutions announces that it has agreed to buy G&W Laboratories’ solid oral dosage drug product manufacturing facility in Sellersville, Pennsylvania. Piramal says it expects to further grow the site’s current strength to support development services “as well as any COVID-19 management drug opportunities.”
• India’s Cipla is granted regulatory approval by the Drug Controller General of India to launch a generic version of Gilead’s remdesivir to treat COVID-19. In May, Gilead extended a voluntary non-exclusive license to Cipla to manufacture and market the drug, Cipremi.
• Gilead Sciences receives the green light from the US Food and Drug Administration to start trials of an inhaled version of remdesivir. The biotech is screening healthy volunteers for Phase 1 trials and hopes to begin studies in patients with COVID-19 in August.
• Novartis says it has discontinued its clinical trial of hydroxychloroquine to treat COVID-19 “due to acute enrolment challenges that have made trial completion infeasible.”
• Glenmark Pharmaceuticals receives manufacturing and marketing approval from India’s drug regulator to launch a generic version of the oral antiviral drug Avigan for the treatment of mild to moderate COVID-19 patients in India. Every patient using the drug must have signed informed consent before treatment initiation.
• Clover Biopharmaceuticals says the first participants have been dosed in a Phase 1 study evaluating its COVID-19 vaccine candidate, SCB-2019. Preliminary safety and immunogenicity results are expected in August 2020. In parallel, the planning for a global Phase 2b/3 vaccine efficacy trial has begun, with initiation targeted by year-end 2020.
• The World Health Organization says it is updating clinical guidance on anti-inflammatory dexamethasone to reflect how and when the drug should be used in COVID-19, after clinical trial results from the UK showed it can be lifesaving for patients on ventilators or for those requiring oxygen.
• PTC Therapeutics says that in the coming days it will start a Phase 2/3 trial to investigate its oral investigative drug, PTC299, as a potential treatment for COVID-19. PTC299 has a novel dual-mechanism of action that addresses the high viral replication of COVID-19 and the uncontrolled inflammatory response that ensues after infection.
• Gilead Sciences says it will soon begin enrolment of an open-label, single-arm Phase 2/3 clinical trial of its antiviral drug, remdesivir, in treating approximately 50 children with moderate-to-severe COVID-19, including new-borns through adolescents. The trial will be conducted at more than 30 sites in the US and Europe.
• Sanofi says it is building a EUR 490 million vaccine production facility, Evolutive Vaccine Facility, in Neuville sur Saône, France to increase its capacity to manufacture them on a massive scale. The facility is designed around a central unit housing several fully digital production modules that make it possible to produce three to four vaccines simultaneously.
• The UK government authorises the country’s National Health Service to use corticosteroid dexamethasone as a treatment for COVID-19 after a clinical trial showed it significantly reduced risk of death in patients on ventilation by as much as 35% and patients on oxygen by 20%, reducing the total 28-day mortality rate by 17%. The government has also placed the drug on the government’s parallel export list, which bans companies from reselling them abroad.
• Biotech Novavax, says it has raised around USD 200 million by selling off 4.4 million shares in a private placement with investment firm RA Capital, boosting its efforts to provide a vaccine against COVID-19.
• CDMO Cobra Biologics says it has signed a supply agreement with AstraZeneca to provide GMP manufacture of the adenovirus vector-based COVID-19 vaccine candidate AZD1222. The production agreement is part of AstraZeneca's recently announced in-licensed programme with the University of Oxford.
• The German government says it is investing EUR 300 million in biopharma firm CureVac, which intends to start the first phase 1/2a clinical trial of its lead mRNA-based COVID-19 vaccine candidate this month.
• The US Food and Drug Administration revokes the emergency use authorization allowing chloroquine phosphate and hydroxychloroquine sulfate to be used to treat COVID-19, saying they are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. The agency also warns that taking hydroxychloroquine in combination with remdesivir “may result in reduced antiviral activity” of the latter.
• China’s Sinovac Biotech says that in a phase II clinical trial, its inactivated COVID-19 vaccine candidate, CoronaVac, induced neutralizing antibodies at a rate “above 90%” in the 600 trial volunteers 14 days after the vaccination.
• Catalent Biologics says it will provide vial filling and packaging capacity to AstraZeneca at Catalent’s manufacturing facility in Anagni, Italy, and prepare for large-scale commercial supply of the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate, AZD1222. Catalent will prepare the facility to enable round-the-clock manufacturing schedules and supply hundreds of millions of doses of the vaccine candidate from August 2020.
• Eli Lilly says the first patient has been enrolled in a Phase 3 randomized, double-blind, placebo–controlled study of rheumatoid arthritis drug, baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19. The study will be conducted in the US, Europe and Latin America.
• Dr. Reddy's Laboratories says it has forged a non-exclusive licensing agreement with Gilead Sciences, to register, manufacture and sell the biotech’s investigational antiviral drug, Remdesivir, a potential treatment for COVID-19, in 127 countries including India. Dr. Reddy’s will receive technology transfer from Gilead for manufacturing of the drug.
• AstraZeneca says it has agreed to supply 400 million doses of the University of Oxford’s COVID-19 vaccine to Europe’s Inclusive Vaccines Alliance, spearheaded by Germany, France, Italy and the Netherlands, with deliveries starting by the end of 2020. The IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative.
• CDMO Emergent BioSolutions says it has signed a USD87 million contract with AstraZeneca to support the manufacturing of the Anglo-Swedish pharma’s viral vector-based vaccine candidate for COVID-19, AZD1222, developed by Oxford University’s Jenner institute working with the Oxford Vaccine Group. Emergent will provide development services, technology transfer, analytical testing, drug substance process and performance qualification and will reserve certain large-scale manufacturing capacity through 2020.
• Moderna announces it will enroll 30,000 patients in the US for a Phase 3 study of its mRNA COVID-19 vaccine candidate, mRNA-1273, expected to begin in July 2020 with a 100 microgram dose level. The company says it remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from its US manufacturing site and collaboration with CDMO Lonza.
• Regeneron Pharmaceuticals says it has started the first clinical trial of REGN-COV2, its investigational dual antibody cocktail for the prevention and treatment of COVID-19. The clinical program consists of four study populations: hospitalized COVID-19 patients, non-hospitalized patients, uninfected people in groups at high-risk of exposure and uninfected people with close exposure to a COVID-19 patient. The placebo-controlled trials will be conducted at multiple sites.
• The European Investment Bank agrees to provide EUR 100 million of debt financing to support the development of BioNTech’s Pfizer-partnered COVID-19 vaccine programme, BNT162. The deal will also allow the company to expand its manufacturing capacity in order to supply the vaccine globally.
• India’s Panacea Biotec announces a collaboration with Irish biotech firm Refana to produce a whole inactivated virus-based vaccine for COVID-19. Under the collaboration, Panacea will be responsible for product development and commercial manufacturing, with the joint venture undertaking clinical development and regulatory submissions globally. Both firms will undertake sales and distribution of the vaccine in their respective territories.
• CDMO Catalent says it has signed an agreement with Spicona to develop a virus-like protein (VLP)-based vaccine against COVID-19. Under the terms of the agreement, Catalent will use its GPEx cell line development technology to develop a cell line expressing the recombinant VLP at its Madison, Wisconsin facility.
• Johnson & Johnson has accelerated the start of the Phase 1/2 clinical trial of its COVID-19 vaccine, Ad26.COV2-S. Initially scheduled to begin in September, the trial is now expected to begin in the second half of July. The company says it is continuing to increase manufacturing capacity and aims to supply more than one billion doses globally in 2021.
• Fujifilm says it will invest 100 billion yen (928 million USD) in the Denmark site of its CDMO Fujifilm Diosynth Biotechnologies to double its current drug substance manufacturing capacity. The COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed-up the response to the global pandemic reserved manufacturing capacity at the site in April.
• Illumina says the US Food and Drug Administration has issued an Emergency Use Authorization for COVIDSeq, its high-throughput, sequencing-based, in vitro diagnostic test for SARS-CoV-2, which can deliver a result in 24 hours.
• AstraZeneca says it has licensed six candidate coronavirus-neutralising antibodies from Vanderbilt University and plans to advance a pair of these mAbs into clinical development as a potential combination therapy for the prevention and treatment of COVID-19 within the next two months.
• Japan’s Daiichi Sankyo says it has agreed a R&D collaboration with the University of Tokyo, RIKEN and Nichi-Iko Pharmaceutical on an inhalation formulation of pancreatitis drug nafamostat for the treatment of COVID-19. The company says researchers have discovered that nafamostat could efficiently inhibit the viral entry process of SARS-CoV-2.
• US government agency Biomedical Advanced Research and Development Authority (BARDA) says it is expanding its agreement with Moderna to increase the domestic manufacturing capacity of the biotech’s mRNA-1273 vaccine being developed for the prevention of COVID-19. Expansion activities are expected to begin mid-year to deliver material and could be available as soon as the end of 2020. Moderna previously announced a new collaboration with CDMO Lonza in the US and the funding supports that manufacturing capacity expansion.
• Shanghai Junshi Biosciences says the first volunteer has been dosed in a Phase I trial of JS016, the first SARS-Cov-2 neutralizing antibody to enter clinical trials in China.
• The European Medicines Agency says it has received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. “The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks,” the agency says.
• CDMO Oxford Biomedica says it has signed a five-year collaboration agreement with the Vaccines Manufacturing and Innovation Centre (VMIC) for the manufacture of viral vector based vaccines, including AstraZeneca’s adenovirus vector based COVID-19 vaccine candidate, AZD1222. VMIC will provide manufacturing equipment for Oxford Biomedica’s two new GMP manufacturing suites within its 7,800 m2 commercial manufacturing centre, Oxbox, in Oxford, UK.
• Japan’s Fujifilm says trials to evaluate its flu medicine Avigan as a potential treatment for COVID-19 may not be completed until July, after local reports said a lack of patients could delay any approval until July or later.
• Chief Investigators of the RECOVERY programme, a major randomised clinical trial in the UK to test a range of potential treatments for COVID-19, conclude that malaria drug, hydroxychloroquine, has “no beneficial effect” in patients hospitalised with COVID-19. “We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY Trial with immediate effect,” they say.
• AstraZeneca agrees a USD750 million agreement with CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million doses of the coronavirus vaccine it is developing in collaboration with the University of Oxford, with delivery starting by the end of the year. The pharma company also says it has reached a licensing agreement with the Serum Institute of India to supply one billion doses for low and middle-income countries, with a commitment to provide 400 million before the end of 2020.
• The Dutch Health Ministry announces that France, Germany, Italy and the Netherlands have created an “Inclusive Vaccine Alliance” to expediate COVID-19 vaccine manufacturing in Europe. The four countries “are jointly exploring various promising initiatives and are in discussion with various pharmaceutical companies,” the ministry says.
• South Korea’s Ministry for Food and Drug Safety says it has approved the emergency use of Gilead Sciences’ antiviral, remdesivir, for the treatment of COVID-19.
• The US government names five finalists developing vaccine candidates for its Operation Warp Speed COVID-19 programme. The selected companies are Moderna, AstraZeneca (in partnership with Oxford University), Pfizer (in partnership with BioNTech), Johnson & Johnson and Merck & Co. Two companies not on the shortlist are GlaxoSmithKline and Sanofi.
• CDMO AGC Biologics partners with Novavax on large-scale production of Matrix-M, the adjuvant component of the biotech’s vaccine candidate, NVX-CoV2373. AGC Biologics will optimize process development for scaled-up production of Matrix-M to increase Novavax’s capacity to deliver doses in 2020 and 2021.
• Testifying at a US Senate Finance Committee hearing, Valisure CEO David Light says the US Food and Drug Administration's ability to adequately inspect drugs manufactured overseas has been negatively impacted by the coronavirus pandemic.
• Gilead Sciences says results from a Phase 3 trial in hospitalized patients with moderate COVID-19 pneumonia. showed that patients taking a 5-day course of its antiviral, remdesivir, were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group.
• Chinese biotech I-Mab says it is ready to take its experimental COVID-19 treatment, TJM2, into Phase 2 trials after positive results for a Phase 1 study in COVID-19 patients with cytokine release syndrome.
• CDMO Emergent BioSolutions announces it has been issued a USD 628 million task order under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), to support the US government’s efforts to accelerate delivery of COVID-19 vaccines.
• Tonix Pharmaceuticals and Fujifilm Diosynth Biotechnologies announce an agreement in which FDB will provide contract manufacturing and development services to support the manufacturing of Tonix’s COVID-19 vaccine candidate, TNX-1800, for clinical trial supply.
• The US Food and Drug Administration adds antidepressant Zoloft to its list of medicines in shortage due to the coronavirus pandemic. One of the drug’s producers, Milan, cites an “increase in demand and API shortage.”
• Roche and Gilead Sciences announce the start of a global phase III clinical study (REMDACTA) for a combination of Actemra/RoActemra and antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia. The study is expected to begin enrolling in June with a target of approximately 450 patients globally.
• CDMO Oxford Biomedica says it has signed a one-year clinical and commercial supply agreement with AstraZeneca for the adenovirus vector-based COVID-19 vaccine candidate, AZD1222, which recently entered clinical trials at multiple sites in the UK. AstraZeneca will have access to Oxford Biomedica’s new UK-based 7,800 m2 commercial manufacturing centre Oxbox, which will provide it with multiple batches of vaccine, the majority of which are expected to be produced throughout 2020.
• Novartis’ gene therapy company, AveXis, says it has signed a manufacturing agreement with the AAVCOVID vaccine program at Massachusetts Eye and Ear and Massachusetts General Hospital to produce its novel genetic vaccine. AveXis will begin manufacturing the vaccine this month while AAVCOVID undergoes further safety and efficacy testing in preclinical studies taking place at academic medical institutions including Mass. Eye and Ear. Clinical trials are scheduled to begin in the second half of 2020.
• CDMO CordenPharma says its existing manufacturing agreement with Moderna has been tweaked so it can manufacture large-scale volumes of the biotech’s lipid excipients for its vaccine candidate, mRNA-1273, against SARS-CoV-2. The amended agreement, which comes into play immediately, now includes CordenPharma Chenôve (FR) and CordenPharma Colorado (US) for the manufacture of larger-scale volumes of lipids.
• Novavax says it has bought Praha Vaccines, in a $167 million deal. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. The facility will provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. Novavax will also work collaboratively with the Serum Institute of India to increase production levels at the Bohumil facility by the end of 2020.
• Merck & Co announces it is acquiring Themis, a privately-held company focused on vaccines and immune-modulation therapies for infectious diseases and cancer. In March, Themis joined a consortium together with the Institut Pasteur and The Center for Vaccine Research at the University of Pittsburgh, supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to develop a vaccine candidate targeting SARS-CoV-2.
Merck & Co also announces respective partnerships with IAVI, a non-profit scientific research organization, to develop an investigational COVID-19 vaccine and with biotech Ridgeback Biotherapeutics to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with COVID-19.
• The World Health Organization announces it will stop a global study into the effectiveness of hydroxychloroquine in COVID-19 patients, in light of recent publications of evidence on the safety and efficacy of the malaria drug as a treatment for COVID-19 patients. “The Executive Group of the Solidarity Trial decided to implement a temporary pause of the hydroxychloroquine arm within the trial as a precaution while the safety data is being reviewed,” the WHO says.
• Novavax says it has enrolled the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.
• University of Oxford researchers says they have begun recruiting for the next phase in human trials of their AstraZeneca-partnered COVID-19 vaccine candidate, AZD1222, in human volunteers.
• Abbott says data from an ongoing clinical study indicates its ID NOW COVID-19 rapid test has a sensitivity of more than 94.7%. Earlier this month, a preliminary study by NYU Langone Health researchers found it could miss nearly 50% of positive cases.
• AstraZeneca will receive USD1 billion from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the University of Oxford’s potential coronavirus vaccine, starting in the autumn. The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial.
• Roche says its Elecsys Anti-SARS-CoV-2 antibody test is live at more than 20 commercial and hospital lab sites throughout the US. The company plans to increase to more than 200 sites over the coming weeks.
• CanSino Biologics and Precision NanoSystems (PNI) announce a co-development agreement for a mRNA lipid nanoparticle vaccine against COVID-19. PNI will be responsible for development and CanSinoBIO will be responsible for pre-clinical testing, human clinical trials, regulatory approval and commercialization.
• The US government signs a USD 354 million contract with pharma start-up Phlow Corporation to manufacture generics and active pharmaceutical ingredients (APIs) needed for drugs in short supply, including COVID-19 treatments, in a move to create the nation’s first strategic stockpile of key ingredients and reduce its dependence on overseas supply.
• Thermo Fisher Scientific announces it has received a contract from the US government to provide highly specialized viral transport media (VTM) for COVID-19 sample collection. The VTM is used during collection of patient samples for transport to laboratories that can test for the presence of the virus. Thermo Fisher currently produces VTM at its site in Lenexa, Kansas, and has ramped production from 50,000 to more than one million VTM-filled tubes per week.
• In a White House briefing, US President Donald Trump tells reporters he is taking antimalarial drug hydroxychloroquine as a precaution against coronavirus. In April, the US Food and Drug Administration issued an advisory saying that the drug has “not been shown to be safe and effective” against COVID-19.
• CDMO Lonza says Dr Moncef Slaoui has stepped down from his position on its board of directors, following his appointment as Chief Advisor for the US government's “Warp Speed” national vaccine program. Dr Slaoui is also divesting his equity interest in biotech Moderna – understood to be worth around USD10 million -- so that there is no conflict of interest in his new role.
• Gilead’s antiviral remdesivir could secure an EU-wide conditional marketing authorisation as a treatment against COVID-19 in the coming days, European Medicines Agency head Guido Rasi tells a hearing at the EU Parliament in Brussels.
• Moderna reports positive interim clinical data of mRNA-1273, saying that in a Phase 1 trial, the vaccine candidate against novel coronavirus (SARS-CoV-2) elicited neutralizing antibodies in all eight participants so far available for analysis.
• The UK Department for Business, Energy and Industrial Strategy announces that the UK government is investing up to GBP93 million to accelerate the construction of the Vaccines Manufacturing and Innovation Centre in Oxfordshire. The funding will ensure the new centre – designed to provide extra capacity if and when a vaccine becomes available -- opens in summer 2021, a year ahead of schedule.
• After testing 24 therapeutic candidates for inhibiting the coronavirus in human lung cells, researchers at the Institut Pasteur Korea publish their findings that anticoagulant Nafamostat appears to be much more effective than remdesivir. The institute has partnered with ten hospitals to launch an investigator-initiated clinical trial.
• The US National Institutes of Health start a Phase 2b clinical trial to evaluate whether a combination of malaria drug hydroxychloroquine and antibiotic azithromycin can prevent hospitalization and death from COVID-19. The trial is being conducted by the AIDS Clinical Trials Group and Teva Pharmaceuticals is donating medications for the study.
• Abbott says it is changing the set of instructions for its point-of-care coronavirus test, ID NOW, after a preliminary study by NYU Langone Health researchers found it could miss nearly 50% of positive cases. “Negative results should be presumed negative, but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay,” the company says.
• In an opinion piece for Swiss newspaper Handelszeitung, Novartis CEO Vas Narasimhan says a vaccine for COVID-19 may not become available until H2 2021. “The ultimate way to deal with this pandemic is likely to be a vaccine against Covid-19. But it will take more time for this - in my estimation, about one and a half to two years,” he writes.
• Exyte and Univercells Technologies announce a partnership for optimized construction of modular standardized and flexible GMP manufacturing facilities for vaccines in response to increased global demand during the COVID-19 pandemic.
• Takeda says it will donate JPY 2.5 billion (USD 23 million) across three UN-led organizations -- the World Food Programme, the United Nations Population Fund and the International Atomic Energy Agency -- to strengthen health systems, improve access to care and supplies, and address food insecurity.
• GreenLight Biosciences announces it has raised USD17 million from new and existing investors to build out its scalable mRNA production capability targeting the production of billions of doses of COVID-19 vaccine. In addition to expanding its manufacturing capacity, the biotech is developing several differentiated mRNA vaccine candidates against SARS-CoV2.
• Sanofi CEO Paul Hudson tells Bloomberg that the US government has the right to the largest pre-order if the company’s COVID-19 vaccine programme is successful because the country has “invested in taking the risk.”
• Japan’s health ministry says pharmaceutical companies will not be required to submit clinical trial results in advance if the safety and efficacy of drugs are confirmed in public studies that have received grants from the ministry or the Japan Agency for Medical Research and Development. This exception to pharmaceutical regulations has been made to expedite the availability of drugs such as Fujifilm’s Avigan, which has been approved against COVID-19.
• Gilead signs non-exclusive voluntary licensing agreements with five India- and Pakistan-based generics manufacturers -- Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan -- to manufacture antiviral remdesivir for distribution in 127 countries.
• The US Food and Drug Administration expands an emergency use authorization (EUA) for Thermo Fisher Scientific’s PCR test for detecting nucleic acid from SARS CoV 2, increasing the number of high-throughput PCT instruments labs can use to run tests.
• Glenmark Pharmaceuticals says it is the first company to start Phase 3 clinical trials on antiviral favipiravir tablets for COVID-19 patients in India. Favipiravir is a generic version of Fujifilm’s Avigan. Glenmark estimates study completion by July/August 2020. The molecule if commercialized, will be marketed under the brand name FabiFlu in India.
• Hikma Pharmaceuticals says the US FDA has cleared its anaesthetic Propofol Injectable Emulsion for use in the US. Propofol Injectable Emulsion is indicated for the initiation and maintenance of sedation and anaesthesia, including for intubated, mechanically ventilated adult patients. It is currently on the FDA's Drug Shortage List, following a surge in demand due to the increase in hospitalized, ventilated patients due to the COVID-19 pandemic. Hikma says it is working quickly to scale up manufacturing and will continue releasing product as soon as it is available.
• The European Medicines Agency’s human medicines committee (CHMP) recommends expanding the compassionate use of Gilead’s remdesivir so that more patients with severe COVID‑19 can be treated. In addition to patients undergoing invasive ventilation, the recommendation now applies to hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or extracorporeal membrane oxygenation.
• The US Food and Drug Administration is collaborating with the Centers for Disease Control to develop a phased approach to restarting on-site inspections at both domestic and foreign manufacturing facilities. The regulator halted inspections in March due to the coronavirus pandemic.
• The US Department of Health and Human Services says Gilead Sciences has committed to supplying approximately 607,000 vials of antiviral remdesivir over the next six weeks to treat an estimated 78,000 hospitalized COVID-19 patients under an EUA granted by the FDA. The donation to the US is part of 1.5 million vials the company is donating worldwide. “Initial supply of remdesivir is likely to be constrained to an even greater degree than we had previously estimated,” RBC Capital analyst Brian Abrahams says in a research note.
• Regeneron CEO, Dr. Leonard Schleifer, says in a live television interview with CNN that he is concerned US manufacturing capacity is “limited” in terms of producing coronavirus related treatments and vaccines.
• Indian health minister Harsh Vardhan tweets that the government has enlisted Zydus Cadila for mass production of the country’s first indigenous test kit for antibody detection of COVID-19, ELISA. “The Drug Controller General has granted commercial production and marketing permission to Zydus,” he says.
• Israel’s RedHill Biopharma announces that the US Food and Drug Administration has approved its application for a Phase 2a clinical study of its drug, opaganib, in patients with confirmed moderate-to-severe SARS-CoV-2 infection.
• The US Food and Drug Administration publishes results of independent performance and accuracy tests on 12 COVID-19 antibody diagnostics tests already authorized for emergency use against the pandemic.
• The US National Institutes of Health says it has begun a clinical trial evaluating the safety and efficacy of a treatment regimen pairing up Gilead’s antiviral remdesivir with Lilly’s anti-inflammatory drug Olumiant (baricitinib) for COVID-19. The trial is expected to open at approximately 100 US and international sites and investigators currently anticipate enrolling more than 1,000 participants.
• India’s Cadila Pharmaceuticals says it has closed operations at its Dholka manufacturing unit after 26 employees from the facility tested positive for COVID-19.
• Sorrento Therapeutics and Mount Sinai Health System say they have teamed up on the development of an antibody cocktail, COVI-SHIELD, to potentially treat COVID-19. The collaboration aims to generate antibody products that would act as a "protective shield" against coronavirus infection, potentially blocking and neutralizing the activity of the virus.
• CDMO Recipharm says it has secured supply of the active pharmaceutical ingredient (API) chloroquine phosphate for its drug Klorokinfosfat RPH Pharma and has started manufacturing the product. While chloroquine products are not currently indicated for treatment or prevention of COVID-19, some clinical studies involving chloroquine and hydroxychloroquine have recently been initiated.
• Endo says it has withdrawn its full-year 2020 financial guidance due to uncertainty regarding the continued impact of the COVID-19 pandemic.
• Moderna says a Phase 2 study of its coronavirus vaccine candidate, mRNA-1273, is imminent. The company is also finalizing protocol for a Phase 3 study of mRNA-1273, expected to begin in the early summer of 2020.
• The CoVIg-19 Plasma Alliance, an industry collaboration of 10 companies including Takeda to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19, says the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH will test the safety, tolerability and efficacy of the therapy in adult patients with COVID-19. The global study is expected to start in the summer.
• Japan approves Gilead Sciences’ antiviral remdesivir as Veklury for patients with severe COVID-19. The exceptional approval references the Emergency Use Authorization of remdesivir in the US.
• Gilead Sciences says it is in discussions with pharmaceutical and chemical manufacturers around the world about expanding global production and supply of its antiviral remdesivir, which has shown promise as a treatment for COVID. “Close coordination of remdesivir manufacturing will be critical,” the company says, adding that it is working to build a consortium of manufacturing partners to pool efforts to help maximize global supply.
• Medical devices industry association AdvaMed announces the launch of an online platform to connect ventilator companies with component suppliers to help quickly scale production and distribution of devices. The new platform was developed pro bono with the Aerospace Industries Association (AIA), Google, and other industry alliances and partners.
• Pfizer and BioNTech announce that the first participants have been dosed in the US in the Phase 1/2 clinical trial for their BNT162 vaccine against COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week. Pfizer sites in Massachusetts, Michigan and Missouri and Puurs, Belgium have been identified as manufacturing centres for COVID-19 vaccine production, with more sites to be selected. Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production capacity.
• Regeneron says it is working to rapidly scale up manufacturing of its investigational antibody ‘cocktail’ treatment, REGN-COV2, for COVID-19, with the goal of having hundreds of thousands of preventative doses available by the end of August 2020. The company moved its leading neutralizing antibodies into pre-clinical and clinical-scale cell production lines in April and plans to begin clinical studies in June 2020.
• In a preliminary modelling exercise, the Institute for Clinical and Economic Review says that Gilead’s antiviral remdesivir can be priced at USD 4,460 per patient and still be cost-effective when being used as a treatment for hospitalized patients with advanced COVID-19 and lung involvement.
• Eli Lilly and China’s Junshi Biosciences agree to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Lilly will receive an exclusive license to conduct clinical development, manufacturing and distribution of products outside of Greater China while Junshi will maintain all rights in China. Lilly will pay an upfront fee of USD10 million and has committed to milestone payments of up to USD245 million.
• Arcturus Therapeutics and Catalent announce a partnership on the expected manufacture of Arcturus’ COVID-19 mRNA vaccine candidate, LUNAR-COV19. Manufacturing at Catalent’s facility in Madison, Wisconsin will support human clinical studies and, if successful, commercialization of the vaccine. Technology transfer will be completed this month and manufacture of the first cGMP batches are expected to be completed by June 2020.
• AbCellera says it has received funding of up to USD 175.6 million from the Canadian government to expand efforts related to the discovery of antibodies for use in drugs to treat COVID-19, and to build technology and manufacturing infrastructure for antibody therapies against future pandemic threats. In March, the firm announced a partnership with Eli Lilly to develop a COVID-19 treatment with the aim of beginning clinical trials in July 2020.
• Vir Biotechnology and Alnylam Pharmaceuticals say they have selected a development candidate for VIR-2703 (also referred to as ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 genome. The companies plan to meet soon with the US Food and Drug Administration and other regulatory authorities to discuss a potential accelerated path for filing an Investigational New Drug or IND equivalent application by the end of 2020.
• Roche announces that its coronavirus antibody test, has received emergency approval by the US Food and Drug Administration. The Swiss pharma company says it has already started shipping the antibody tests to laboratories around the world and will ramp up production capacity to provide “high double-digit millions” of tests in May to healthcare systems in countries accepting the European CE regulatory mark as well as the US.
• The US Food and Drug Administration issues an emergency use authorization for Gilead’s antiviral remdesivir for the treatment of COVID-19 in hospitalized patients with severe disease. The agency says the investigational drug was shown in a clinical trial to shorten recovery in some patients.
• Moderna has signed up CDMO Lonza in a 10-year strategic collaboration agreement to enable larger scale manufacture of its mRNA vaccine (mRNA-1273) against the novel coronavirus. Under the terms of the agreement, manufacturing suites will be established at Lonza’s facilities in the US and Switzerland. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza US in July 2020.
• The US Food and Drug Administration publishes guidance to clarify exemptions and exclusions under the Drug Supply Chain Security Act to help ensure adequate distribution of prescription drugs during the COVID-19 pandemic.
• CDMO Fujifilm Diosynth Biotechnologies, says it will reserve manufacturing capacity at its facility in Hillerød, Denmark for a future COVID-19 therapy for the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed-up the response to the global pandemic. FDB will work with a selected pharmaceutical partner to manufacture and supply the therapy for patients with COVID-19 in lower-income countries.
• The European Medicines Agency’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of Gilead’s antiviral remdesivir for the treatment of COVID-19. A rolling review is one of the regulatory tools available to the agency to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic.
• AstraZeneca and the University of Oxford announce a global development and distribution agreement for the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection. AstraZeneca says the partnership aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group. Under the agreement, AstraZeneca would be responsible for development and worldwide manufacturing and distribution of the vaccine.
• Johnson & Johnson signs its second COVID-19 manufacturing deal for its lead COVID-19 vaccine candidate, partnering with Catalent to ramp up capacity and prepare for large-scale commercial manufacturing at the CDMO’s facility in Bloomington. Catalent plans to hire approximately 300 additional employees for the programme starting in July 2020 to meet operational readiness and 24×7 manufacturing schedules by January 2021.
• Data from a clinical trial shows that Gilead’s experimental antiviral, remdesivir, “has a clear-cut, significant positive effect in diminishing the time to recover” from COVID-19, the US’s top infectious disease expert National Institute of Allergy and Infectious Diseases Director, Dr Anthony Fauci tells reporters. Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from the randomized, controlled trial involving 1063 patients, which began on February 21.
• AstraZeneca says it is confident that its clinical trials programme will not be affected by the coronavirus pandemic. The company says it has implemented mitigation strategies such as home-based treatment and monitoring options, moving patient recruitment to less-affected regions, and planning for accelerated recruitment once the pandemic has receded. “Having assessed the COVID-19 impact across the pipeline, the company does not expect material delays to anticipated dates of late-stage and lifecycle-management news flow in 2020 and 2021,” it says.
• India’s Strides Pharma Science says it has developed and commercialized a generic version of Fujifilm’s flu antiviral Avigan (favipiravir) which has shown promise as an experimental treatment for COVID-19. The drug is currently being exported to Gulf Cooperation Council countries to treat patients under their treatment program for COVID-19.
• CDMO CordenPharma tells its employees and manufacturing facilities to cease and cancel all business travel and face-to-face meetings until the end of May, and to convert all meetings into video or teleconference calls. All customer-related quality audits originally scheduled in Q2 of 2020, have been rescheduled to H2, although any regulatory agency audits that may arise during this period will still go ahead.
• Novartis says it plans to initiate a Phase III clinical trial of its interleukin (IL)-1β blocker, canakinumab, in patients with COVID-19 pneumonia. The company aims to enrol 450 patients at multiple medical centres across France, Germany, Italy, Spain, UK and the US. Top-line results are anticipated late summer 2020.
• Innate Pharma announces that the first patient has been dosed in a randomized, double-blind Phase II clinical trial of its anti-C5aR antibody, avdoralimab (IPH5401), in COVID-19 patients with severe pneumonia.
• Japan’s Shionogi announces it is developing a recombinant protein vaccine for the novel coronavirus and plans to initiate clinical trials this year. The company says it is looking to offer the vaccine for 10 million people.
• Merck & Co and the Institute for Systems Biology announce a new research collaboration to investigate and define the molecular mechanisms of SARS-CoV-2 infection and COVID-19 and identify targets for medicines and vaccines.
• Japanese prime minister Shinzo Abe tells a parliamentary session that the government will soon approve Gilead’s anti-viral remdesivir for the treatment of COVID-19, in what will be the country's first such decision amid the pandemic.
• Sanofi and Regeneron Pharmaceuticals say that after preliminary results from the Phase 2 portion of an ongoing Phase 2/3 for IL-6 receptor Kevzara® (sarilumab) to treat sever and critically ill patients with COVID-19, they will scale back the trial so that only ‘critical’ patients will continue to be enrolled. The phase 3 trial will exclude the 200-mg dose, which showed little efficacy at the phase 2 stage.
• World leaders including French president Emmanuel Macron and German chancellor Angela Merkel join a video conference to launch a World Health Organisation initiative to speed development of therapies, tests and vaccines to prevent, diagnose and treat COVID-19.
• In a safety communication, the US Food and Drug Administration says it has received reports of serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines. The agency recommends that the drugs, when used for COVID-19, should be limited to clinical trial settings or for treating certain hospitalized patients under an Emergency Use Authorisation.
• AstraZeneca in partnership with St. Luke’s Mid America Heart Institute initiates a Phase III trial to assess the potential of diabetes drug Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure. The global, double-blind study will enrol around 900 patients at US and European clinical sites.
• Gilead disputes the findings of a clinical trial in China which said its antiviral remdesivir was ineffective in treating patients with COVID-19. The company said the information was “prematurely posted” on the World Health Organisation website and has since been removed. “Furthermore, we believe the post included inappropriate characterizations of the study. The study was terminated early due to low enrolment and, as a result, it was underpowered to enable statistically meaningful conclusions. As such, the study results are inconclusive,” Gilead says.
• Risks of disruption to the global medicine supply chain are rising as emerging markets are likely to join developed markets in implementing COVID-19 lockdown measures in the coming weeks, according to a Fitch Solutions report. “COVID-19 has highlighted vulnerabilities in the medical manufacturing supply chain, most notably in the US. We believe that over the longer term, governments may aim to source more key pharmaceutical ingredients locally as opposed to the current heavy reliance on China, and to a lesser degree India,” the report says.
• India’s key pharmaceutical manufacturing hub in Baddi, Himachal Pradesh, has been severely impacted after the region was locked down on April 12. According to the Economic Times, 50 pharmaceutical manufacturing facilities, including those of Wockhardt, USV Pharma and Sun Pharmaceuticals have stopped operations while several others are operating at vastly reduced capacities.
State deputy drug controller Manish Kapoor told the newspaper that units of Dr Reddy’s Laboratories, Abbott, Glenmark Pharma and Cadila are all operating at a fraction of their normal capacities.
• The European Medicines Agency launches its enhanced fast-track monitoring system to help prevent and mitigate supply issues with medicines used for treatment of COVID-19. Under this system, each pharmaceutical company will report to the EMA and national competent authorities all current and anticipated shortages, both for centrally and nationally authorised medicines.
• Pfizer and BioNTech announce that the latter’s BNT162 vaccine program has been approved to enter a Phase I/II clinical trial in Germany. The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany. The development partners will also conduct trials for BNT162 in the US upon regulatory approval, which is expected shortly.
• Teva says its supply chain remains largely uninterrupted and there is an adequate inventory of products across its network. The generic company has donated nearly 18 million units of hydroxychloroquine and 500,000 units of azithromycin to more than 26 countries.
• Chinese CDMO Wuxi Biologics says it has donated more than 1,600 masks to medical facilities in Leverkusen, Germany, where it has completed the acquisition of a drug manufacturing plant from Bayer.
• Bayer says its Canadian subsidiary is partnering with the Population Health Research Institute in a clinical research program to identify potential treatments for COVID-19. Two studies will evaluate the safety and efficacy of different combination therapies including Bayer’s chloroquine and interferon beta-1b. Bayer will make a financial commitment of CAD 1.5 million (approx. 1 million euros) towards the studies and will supply study drugs to support the research.
• Indian generics firm Cipla says it has set up an INR 250 million (USD 3.25 million) dedicated COVID-19 fund to support patients, the healthcare ecosystem and communities.
• Merck & Co says it is making a number of changes to its US patient assistance programme to help patients who have lost their job or cannot access healthcare during the COVID-19 pandemic, including assessing their real-time financial situations, providing assistance with expiring enrolments, and offering new options to collect signatures on enrolment forms. The company will also be making changes to other US access and assistance programs, including a temporary USD 0 co-pay for certain products for eligible privately insured patients enrolled in Merck’s access programme and relaxed certain refill restrictions related to coupon use.
• Hikma Pharmaceuticals says it is experiencing a significant increase in demand for respiratory, pain, anaesthetic, sedatives, anti-viral and anti-infective medicines due to the outbreak of COVID-19 and is therefore prioritizing their manufacture. “We have been proactively managing our inventory and stock levels, transportation options and the availability of raw materials and component parts. We continue to work closely with our supplier networks to address demand-related shortages caused by this fast-evolving situation,” it adds.
• In an update, CDMO Catalent says it is working with several customers on multiple COVID-related antivirals, vaccines, diagnostics and treatments. The company has been declared an essential business by all the national and local governments where it operates and it has paid a ‘thank you’ bonus to lab, development and production employees at its 40+ global facilities.
• API manufacturer Wavelength Pharmaceuticals says it has expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients. “Demand for these products, including Midazolam, Cisatracurium, and Rocuronium, has skyrocketed as a result of the global coronavirus pandemic,” it says.
• Alexion Pharmaceuticals says it plans to start a Phase 3 study to investigate its rare disease biologic Ultomiris (ravulizumab-cwvz) in treating patients with COVID-19 and suffering severe pneumonia or acute respiratory distress syndrome (ARDS). The 270 patient study is expected to begin in May.
• Novartis says it has US Food and Drug Administration approval to go ahead with a Phase III clinical trial of malaria drug hydroxychloroquine for the treatment of 440 hospitalized US patients with COVID-19 disease. The clinical trial drug supply will be provided by the firm’s generics and biosimilars division, Sandoz.
• Roche says its newly developed serology test, Elecsys Anti-SARS-CoV-2, can detect COVID-19 antibodies in patients who have previously been exposed to the virus. The company aims to have the test available by early May in European countries accepting the CE mark. It says it is also actively working with the US Food and Drug Administration for an Emergency Use Authorisation.
• Bayer says it is donating EUR 1 million to the 'All united against the virus' alliance set up by the Fondation de France, the Assistance Publique – Hôpitaux de Paris (AP-HP) hospital network and the Pasteur Institute. The money will be used to support caregivers, patients and their families, to fund research projects and to develop antibody detection tests, treatments and vaccines.
• Sanofi and Luminostics are working on an at-home test for COVID-19, with the US start-up contributing its consumer-diagnostics technology that utilizes a consumer smartphone’s optics.
• Biogen, Broad Institute of MIT and Harvard, and Partners HealthCare form a consortium to build and share a COVID-19 biobank to help scientists study a large collection of de-identified biological and medical data to advance knowledge and search for potential vaccines and treatments. Biogen employees were among the first people in Massachusetts to be diagnosed with and recover from COVID-19 after a leadership conference in February.
• Moderna is awarded a grant of up to USD483 million from US government agency Biomedical Advanced Research and Development Authority (BARDA) to accelerate development of its mRNA vaccine candidate (mRNA-1273) against SARS-CoV-2. The money will also be used to fund manufacturing process scale-up to enable large-scale production in 2020 for pandemic response. Moderna plans to hire 150 new team members to support these efforts.
• AstraZeneca donates 3 million surgical masks for US healthcare workers battling COVID-19. The masks, which were procured through the company’s manufacturing relationships in China, will be distributed by Direct Relief to health facilities in areas with the most significant public health need.
• CDMO Lonza says it has not suffered any major disruptions to business continuity caused by challenges to supply, citing one capsule production site in Colmar, France, which experienced a temporary slowdown for a few days. “A small number of bulk raw material supplies have been disrupted, and there have been some inbound and outbound logistics delays,” it says.
It adds that its Pharma, Biotech & Nutrition unit has received in excess of 40 clinical and commercial enquiries regarding projects relating to COVID-19. “While the business cannot participate in every initiative, it is focusing on a small number of key development projects relating to both vaccines and therapeutic treatments,” it says.
• Kaneka says it has signed an agreement to supply APIs to Fujifilm for its influenza antiviral, Avigan, which the Japanese government is stockpiling for potential use against COVID-19. “We have already started supplying PCR reagents used for COVID-19 tests,” it says.
• India’s Directorate General of Foreign Trade relaxes an export ban on paracetamol finished dosage formulations. However, export restrictions on paracetamol APIS remain in place. A common OTC painkiller and fever medication, paracetamol has been in even higher demand since the COVID-19 outbreak.
• Ex-GlaxoSmithKline CEO, Andrew Witty, currently president of UnitedHealth, is taking a leave of absence to co-lead the World Health Organization's efforts to develop a vaccine for COVID-19.
• Biotech firms Dynavax and Sinovac announce a partnership to develop a vaccine to prevent COVID-19. The collaboration will evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate, with Dynavax’s advanced adjuvant, CpG 1018.
• The US Food and Drug Administration starts publishing an ‘At-a-Glance Summary’ that captures the agency's major activities in the fight against COVID-19. The agency intends to regularly update this resource on efforts related to medical products and equipment, vaccines and therapeutics.
• Japan’s Fujifilm says it has expanded its manufacturing capacity to significantly increase production of its influenza antiviral drug Avigan for treating patients with COVID-19.
The company expects to progressively increase monthly production of Avigan up to 100,000 treatment courses by July 2020, approximately 2.5 times more compared to the beginning of March, when the company first began its current production run. In addition, Fujifilm plans to further accelerate production up to 300,000 treatment courses by September 2020.
• Abbott launches its lab-based IgC antibody test that identifies if a person has had COVID-19. The test, which has been made available as part of the FDA notification without an Emergency Use Authorization pathway, will initially be available on more than 2,000 instruments that can run up to 100-200 tests per hour.
The company also says it is significantly scaling up its manufacturing for antibody testing and is expecting to immediately ship close to 1 million tests this week to US customers and will ship a total of 4 million tests in total for April.
• In its annual report, CDMO Recipharm says recent COVID-19-related events have highlighted the risks of relying on suppliers who are located on the other side of the world and anticipates that customers will re-evaluate their supply chains and business continuity plans.
“This is likely to favour more localised production and focus on reliable suppliers in a way we have not seen previously which with our global footprint means we should be well placed. It is also not unlikely that we will see a slowdown in our development services business as our partners struggle to complete (or even initiate) clinical trials or focus on established projects,” says CEO Thomas Eldered.
• Bristol Myers Squibb announces it will hold its 2020 annual shareholders meeting on 5 May virtually due to public health concerns relating to the COVID-19 pandemic.
• San Francisco-based biotech Flow Pharma says it is partnering with Oakwood Laboratories to use the CDMO’s microsphere-based manufacturing operations to make doses of its FlowVax COVID-19 vaccine for clinical testing.
• Sanofi and GlaxoSmithKline sign a letter of intent to develop an adjuvanted vaccine for COVID-19. Sanofi will contribute its S-protein COVID-19 antigen, based on recombinant DNA technology while GSK will contribute its pandemic adjuvant technology. The companies plan to start phase I clinical trials in the second half of 2020 and complete development required for availability by the second half of 2021.
• AstraZeneca says it will start a clinical trial to assess the potential of its BTK inhibitor Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 in severely ill patients.
• Innate Pharma says it will hold its annual general meeting on 19 May virtually with shareholders invited to vote by mail or proxy due to the COVID-19 epidemic.
• South Korean drug developer Celltrion says it has successfully selected the most potent antibody candidates to neutralise SARS-CoV-2 and hopes to start human testing in July.
• China’s CanSino Biologics becomes the first company in the world to advance to advance a potential vaccine - Ad5-nCOV -- for coronavirus into Phase II clinical trials.
• Vir Biotechnology and Samsung Biologics sign a manufacturing agreement valued at around USD362 million under which the Korean CDMO will perform large scale manufacturing services for Vir's SARS-CoV-2 monoclonal antibody program.
• BioCryst Pharmaceuticals says it has started enrolment for a clinical trial of its antiviral galidesivir in patients with COVID-19. The trial is being funded by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
• The cost of manufacturing Gilead’s remdesivir – a potential treatment for COVID-19 -- could be as little as USD9 while hydroxychloroquine could be made for as little as USD1, according to a study published in the Journal of Virus Eradication.
• Sanofi says it is donating 100 million doses of Plaquenil (hydroxychloroquine) across 50 countries. The company has already increased its production capacity by 50% and is on track to further increase production over the coming months, it adds. Ongoing global clinical studies are assessing the efficacy and safety of hydroxychloroquine in the treatment of COVID-19.
• The US Food and Drug Administration issues an emergency use authorization authorization to Terumo BCT and Marker Therapeutics AG for a blood purification system to treat patients with COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. The product works by reducing the amount of cytokines and other inflammatory mediators.
• Pfizer says a Phase 2 investigator-initiated study for the use of tofacitinib, a JAK inhibitor, in patients with SARS-CoV-2 interstitial pneumonia is about to start in Italy.
• Mylan says its expedited manufacturing of hydroxychloroquine has resulted in stocks being available ahead of schedule. The company is donating 10 million tablets of hydroxychloroquine sulphate to the US Department of Health and Human Services (HHS), and has also begun shipping additional product to US wholesalers to address shortages for FDA-approved use.
• Fujifilm announces it is starting a phase II clinical trial of its antiviral drug Avigan in the US for patients with COVID-19. The drug is approved in Japan as an influenza treatment, with phase III clinical trials for COVID-19 patients in Japan having already started at the end of March.
• Analysts at Morningstar say the coronavirus pandemic will affect Big Pharma and Big Biotech companies in two major ways: an economic slowdown, likely causing a 4.6% hit to 2020 global GDP (implying a 1.4% decline in 2020), and a disruption in the use of drugs, vaccines, and consumer healthcare products. “However, the highly inelastic demand for most drugs should largely offset any recessionary impact,” they add.
• The European Commission publishes its guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak. Within the communication, it states the importance of implementing green lanes to facilitate transport of medicinal products, raw materials, intermediates, APIs, substances of human origin (such as plasma) and related materials such as packaging. “In order to effectively facilitate transport, trucks travelling to/from manufacturing sites after or before pick-up must also be allowed to cross borders without delays,” it says.
• As part of the UK Government’s announcement of a new five pillar plan to boost testing for COVID-19, AstraZeneca, GlaxoSmithKline and the University of Cambridge are setting up a COVID-19 high throughput testing laboratory at the University’s Anne McLaren Building. The facility will also be used to explore the use of alternative chemical reagents for test kits to help overcome current supply shortages. The partners are also working to provide process optimisation support to UK national testing centres in Milton Keynes, Alderley Park and Glasgow for COVID-19, providing expertise in automation and robotics.
• US Food and Drug Administration commissioner Stephen Hahn says that since the agency issued its policy to allow developers of serological tests to identify patients that have developed an immune response to market them without FDA review, over 70 tests are available for use. “However, some firms are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19. The FDA will take appropriate action against firms making false claims or marketing tests that are not accurate and reliable,” he says.
• The Indian government relaxes an export ban on anti-malarial drug hydroxychloroquine – which the US administration has touted as a potential treatment for sufferers of COVID-19 -- just 24 hours after US President Donald Trump warned of “retaliation” if the measure was not lifted. “After having confirmed the availability of medicines for all possible contingencies currently envisaged, these restrictions have been largely lifted,” says Indian Ministry of External Affairs (MEA) spokesman Anurag Srivastava.
• Bristol Myers Squibb announces an expansion of its patient support programs to help unemployed US patients who have lost their health insurance due to the COVID-19 pandemic. The expansion offers access to any branded Bristol Myers Squibb medicine for free.
• IQVIA launches its COVID-19 Trial Matching Solution within the US, an online platform that matches individuals with specific COVID-19 studies to accelerate clinical research projects.
• British prime minister Boris Johnson is moved into an intensive care unit at St Thomas’ Hospital in London as his condition worsens, and foreign secretary Dominic Raab will deputise for him “where necessary.”
• GlaxoSmithKline and Vir Biotechnology announce an agreement to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. GSK will make an equity investment of USD250 million to gain access to Vir’s monoclonal antibody platform technology. The initial focus of the collaboration will be to accelerate the development of two antibody candidates identified by the platform, VIR-7831 and VIR-7832, that show potential in neutralising SARS-CoV-2 and could move into phase 2 clinical trial within the next three to five months.
• Industry organisation Indian Pharmaceutical Alliance releases a set of best practices for employee safety in pharmaceutical manufacturing during the COVID-19 pandemic.
• India lifts export restrictions on 12 APIs and their formulations including antibiotics, vitamins and hormones with immediate effect, according to a Directorate General of Foreign Trade notification. Paracetamol and hydroxychloroquine are notable omissions from the list.
• Pfizer commits USD40 million to global anti-COVID-19 efforts. The Big Pharma firm says it is also responding to patient and healthcare provider needs by evolving its US Patient Assistance Program and donating additional medicines and vaccines around the world.
• Thermo Fisher Scientific says that due to the COVID-19 pandemic, it is withdrawing its 2020 annual financial guidance, which was provided on January 30. “As the pandemic spread from China to countries worldwide, the company saw a significant reduction in customer activity by late March. Given the ongoing uncertainty of the scope, duration and impact of the pandemic, Thermo Fisher is currently unable to reasonably estimate its annual financial performance,” it says. The company adds it believes its long-term prospects remain excellent and that the pandemic is also likely to result in additional future funding opportunities for its customers.
• British prime minister Boris Johnson is admitted to hospital for tests as a “precautionary step” after suffering persistent symptoms of coronavirus since testing positive ten days earlier, says a Downing Street spokesman.
• In an open letter, Gilead CEO Daniel O’Day says the biotech company has managed to reduce the end-to-end manufacturing timeline for its antiviral remdesivir – which has shown potential to treat patients with severe COVID-19 -- from one year to around six months. “Our existing supply, including finished product ready for distribution as well as investigational medicine in the final stages of production, amounts to 1.5 million individual doses,” he writes, adding that Gilead is providing this existing supply at no cost to treat patients with the most severe symptoms of COVID-19.
• India’s Directorate General of Foreign Trade announces an immediate blanket ban on exports of hydroxychloroquine “without any exceptions.” The trade regulator introduced the ban on March 25 but allowed limited exceptions on humanitarian grounds and for meeting prior commitments. The malaria and arthritis treatment has been touted by US president Donald Trump as showing promise in treating patients with COVID-19. At the same time, the DGFT places export restrictions on most types of diagnostics kits and reagents.
• in response to continued respirator shortages, the US Food and Drug Administration issues a new Emergency Use Authorization for non-NIOSH-approved respirators made in China, which makes KN95 respirators – the Chinese equivalent of the US standard N95 -- eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic.
• GlaxoSmithKline teams up with Xiamen Innovax Biotech to evaluate a recombinant protein-based coronavirus vaccine candidate (COVID-19 XWG-03), being developed by Innovax with Xiamen University. GSK will provide Innovax with its pandemic adjuvant system for preclinical evaluation of the COVID-19 vaccine. GSK says it is also exploring options to share available manufacturing capacity, to help provide scale manufacturing and production for an eventual vaccine.
• Generics industry association Medicines for Europe supports a call by the European University Hospital Alliance for European coordinated efforts to prevent shortages of ICU medicines – which include sedatives, muscle relaxants, antibiotics and anaesthetics -- amid rising demand.
• The US Food and Drug Administration says it is revising guidance regarding blood donor eligibility due to significant blood shortages in the US due to the coronavirus pandemic. “These changes are based on recently completed studies and epidemiological data, leading the FDA to conclude that the polices could be modified without compromising the safety of the blood supply,” the agency says.
• Astellas Pharma’s US division and the Astellas Global Health Foundation announce they are providing up to USD2 million to meet the urgent demand for resources to help patients, healthcare workers and first responders in the fight against COVID-19.
• Novartis says it plans to start a clinical trial of its JAK inhibitor, Jakavi (ruxolitinib), in patients with COVID-19 associated cytokine storm, a form of severe immune overreaction that can result from coronavirus infection.
• Roche Canada announces its COVID-19 Innovation Challenge, a competition to bring forward innovative ideas to fight the pandemic. Individuals or teams can submit a proposed innovative solution to a challenge or issue that they have identified as a result of the COVID-19 pandemic by April 10. Winning submissions from individuals are eligible for funding of up to USD50,000 per programme, and team submissions are eligible for funding of up to USD100,000 per programme.
• Denmark’s Novo Nordisk says it has ample supplies of medicines, including insulin, and should be able to fulfil orders and replenish pharmacies in the US throughout the pandemic. However, it warns that due to periodic increases in demand, “there may be times when local pharmacies are temporarily out of stock of diabetes medicines.”
• Amgen and Adaptive Biotechnologies announce a partnership to develop neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19. The companies say they will begin work immediately and finalize financial details and terms in the coming weeks.
• The US Food and Drug Administration approves Celularity’s Investigational New Drug application for its CYNK-001 cell therapy in adults with COVID-19. The fast-track approval comes a week after President Donald Trump’s personal attorney Rudy Giuliani expressed his support for expedited trials.
• The US Food and Drug Administration says to date, 23 emergency use authorizations have been issued for coronavirus diagnostic tests. The regulator adds that more than 110 laboratories have begun testing under the policies set forth in its COVID-19 policy for diagnostic tests.
• Eiger BioPharmaceuticals says it does not expect to complete enrolment for its HDV Phase 3 D-LIVR clinical trial until 2021 due to the COVID-19 pandemic. “The company is working closely with clinical sites across twenty countries to enable remote patient study visits, use of local labs for safety monitoring, and home delivery of study drug to ensure study continuity and integrity,” it says.
• The European Medicines Agency says chloroquine and hydroxychloroquine, currently authorised for malaria and certain autoimmune diseases but being investigated for their potential to treat COVID-19, should only be used in clinical trials or emergency use programmes. “It is important that… patients [with auto-immune conditions] are still able to obtain them and do not face shortages caused by stockpiling or use outside the authorised indications,” the agency says.
• Johnson & Johnson reschedules its 2020 medical devices business review that was planned to take place on May 13 due to the coronavirus outbreak.
• Merck & Co, Pfizer and Eli Lilly announce medical service volunteer programmes enabling employees who are licensed medical professionals to aid in the fight against COVID-19 while maintaining their base pay.
• South Korean CDMO Samsung Biologics says its supply chain management team performed has concluded that although some cargoes from US and China could be delayed due to flight cancelations, the COVID-19 situation does not pose any immediate threat to its raw material supply.
• Roche Diagnostics “sincerely apologizes” in China for referring to coronavirus as ‘Wuhan virus’ on three of its testing kits on its Argentinian website. It says the labelling was done in early January, before the WHO had named the virus uniformly.
• EUSA Pharma reports positive preliminary findings from its study at the Papa Giovanni XXIII Hospital in Bergamo, northern Italy, for SISCO (siltuximab) treating COVID-19 patients who have developed serious respiratory complications.
• AbbVie is donating USD35 million to support COVID-19 relief efforts. In the US, the money will be used to support healthcare capacity for hospitals as well as protect vulnerable populations by enabling access to food and essential supplies. In Europe, the donation will provide critical equipment and supplies to patients and front-line healthcare workers in the hardest-hit countries.
• Med tech firm Smith+Nephew confirms it has been contracted by the UK government to build a ventilator designed specifically for large scale production. The OxVent ventilator results from a collaboration of scientists, clinicians and medical technology manufacturers from the University of Oxford, King’s College London and Smith+Nephew and is currently under review by the UK Medicines and Healthcare products Regulatory Authority.
• Brii Biosciences announces a partnership with China’s Tsinghua University and 3rd People’s Hospital of Shenzhen to develop and commercialize monoclonal antibodies -- characterized from recovered patients in China -- to fight COVID-19.
• In an SEC filing, biotech firm CRISPR Therapeutics says that as a result of the coronavirus pandemic, “we may experience disruptions that could severely impact our business, preclinical studies and clinical trials.” It says that with regards to trials for its candidate CTX001TM for severe hemoglobinopathies -- specifically, transfusion-dependent beta thalassemia and severe sickle cell disease -- ICU beds and related healthcare resources are anticipated to become significantly constrained and so no additional patients are currently scheduled to begin dosing in either study at this time.
• Gilead announces that it has started two Phase 3 studies of its investigational antiviral treatment, remdesivir, in patients with moderate to severe COVID-19 in the UK. Both have been given urgent public health research status by the Chief Medical Office and will initially involve 15 centres in the country.
• Flexion says that due to the “extraordinary impacts of the novel coronavirus global pandemic”, it is withdrawing its 2020 revenue guidance for its osteoporosis knee pain treatment Zilretta. The company is also suspending its active clinical trials including the Phase 1 trial of its investigational intra-articular gene therapy candidate, FX201, in patients with osteoarthritis of the knee, and the Phase 2 trial for Zilretta in patients with shoulder OA or adhesive capsulitis. The decision was based on recent FDA guidance on ensuring patient safety and minimising risk to trial integrity from disruptions caused by COVID-19.
• Jazz Pharmaceuticals says that it entered 2020 with over USD1 billion in cash and investments and access to significant additional liquidity so it sees a limited current financial impact from COVID-19. “However, given the global economic slowdown, reduced field-based interactions with healthcare professionals and the uncertainty surrounding the scale and duration of the pandemic, the company, at this time, cannot rule out future impact on its business and associated guidance,” it adds.
• The US Food and Drug Administration says it has launched a program to speed up the development of treatments for COVID-19. Under the Coronavirus Treatment Acceleration Program, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible.
• The US government is in discussions with India over a possible relaxing of restrictions on API exports from India imposed at the start of March.
• China is stepping up its efforts to produce and ship APIs with a focus on meeting international demand, particularly for those showing potential to treat the COVID-19 disease, says Xin Guobin, deputy minister of industry and information technology, adding that the main cause of recent export bottlenecks is a combination of greatly reduced sea freight and international shipping and increased transportation costs.
• Qiagen says it has received FDA emergency use authorization for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test which it describes as the first syndromic testing solution to be deployed which can differentiate novel coronavirus from 20 other serious respiratory infections. The firm had announced on March 24 that it had begun shipping QIAstat-Dx SARS-CoV-2 test kits to the US under a new FDA Policy allowing the kits to be made commercially available.
• In an SEC filing, Amgen says at this stage of the COVID-19 pandemic, it cannot rule out future impact on its business. “Since the pandemic was declared, we have observed fewer patient/doctor interactions and our representatives are having fewer visits with health care providers which may affect our sales in the future,” it says. However, the biotech adds that it does not expect any significant delays for its “potentially pivotal” AMG 510 Phase 2 non-small cell lung cancer study.
• Genfit says it does not anticipate any delays to the unblinding of its RESOLVE-IT Phase 3 trial in NASH with fibrosis. The database was locked at the end of February and the biotech is awaiting feedback from the FDA.
• CDMO Cobra Biologics says it has joined a consortium led by the Jenner Institute, Oxford University to develop, scale-up and produce a potential adenoviral vaccine candidate for fast-tracked clinical trials for COVID-19. ChAdOx1 is expected to be the UK’s first COVID-19 vaccine. The ChAdOx1 consortium also includes the University of Oxford Jenner Institute, University of Oxford Clinical Biomanufacturing Facility, the Vaccines Manufacturing and Innovation Centre (VMIC), Advent Srl, Pall Life Sciences and Halix BV.
• In a letter to customers, CordenPharma says it has halted routine manufacturing at its Bergamo facility in northern Italy for one week from 26 March to 1 April due to supply chain interruption and staffing issues. The CDMO says it will use the time to perform routine maintenance programs that would normally occur during the summer shutdown. Bergamo is one of the cities in Lombardy hit hardest by the coronavirus outbreak.
• The US Food and Drug Administration approves academic medical centre Houston Methodist’s therapy to transfuse donated plasma from a recovered COVID-19 patient into a critically ill patient.
• Allergan announces that The Allergan Foundation has so far donated USD 2 million to more than 70 organizations responding to the local impact of the COVID-19 pandemic. Among the organizations receiving grants are New York Community Trust NYC COVID-19 Response & Impact Fund, Community Food Bank of New Jersey, Orange County, California United Way, Central Texas Food Bank and Freestore Foodbank, Cincinnati, Ohio.
• Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA) announce a USD1 billion deal to progress their lead COVID-19 vaccine candidate. Human clinical studies should begin by September 2020 at the latest and the first batches could be available for emergency use authorization in early 2021. J&J is also expanding its global manufacturing capacity in order to be able to supply more than one billion doses.
• The European Commission publishes conformity assessment procedures for 3D printing and 3D printed products – such as medical devices -- to be used in a medical context for COVID-19. It says that 3D printed products may qualify as medical devices or accessories and must therefore fulfil all applicable requirements of Directive 93/42/EEC6 concerning medical devices.
• Novartis announces that its generics unit Sandoz has started to ship 30 million doses of hydroxychloroquine to the US Department of Health and Human Services for use in clinical studies to test its effectiveness in people who have tested positive for COVID-19. The shipment is part of a previously announced donation of 130 million tablets to be distributed internationally. Novartis is also donating 20,000 doses to the University of Washington for a COVID-19 PEP clinical trial.
• Sanofi and Regeneron say the first patient outside of the US has been treated with their novel interleukin (IL)-6 receptor inhibitor Kevzara (sarilumab) in the second phase of their clinical programme for patients hospitalized with severe COVID-19. Trials have now started in Italy, Spain, Germany, France, Canada, Russia and the US.
• The US Food and Drug Administration issues an Emergency Use Authorization for certain imported disposable respirators that are not National Institute for Occupational Safety and Health (NIOSH)-approved for use by health care professionals.
• In an open letter, Gilead CEO Daniel Day says that if the biotech firm’s antiviral remdesivir is approved for the treatment of COVID-19 “we will work to ensure affordability and access so that remdesivir is available to patients with the greatest need.” He adds that the investigational drug is being made available for severely ill patients who cannot enroll in a trial via a “compassionate use” programme.
• The US Food and Drug Administration issues an Emergency Use Authorization to allow 30 million doses of hydroxychloroquine sulfate and chloroquine phosphate products donated by pharma companies Sandoz -- Novartis’s generics unit -- and Bayer to the Strategic National Stockpile(SNS) to be distributed and used for certain hospitalized patients with COVID-19.
• The European Medicines Agency responds to media reports questioning whether angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartans) -- used for treating high blood pressure, heart failure or kidney disease -- worsen COVID-19. “The speculation that ACE-inhibitors or ARBs treatment can make infections worse in the context of COVID-19 is not supported by clinical evidence,” it says.
• Sun Pharma says it is donating INR 250 million (USD 3.3 million) of hydroxychloroquine, azithromycin and other related drugs and hand sanitizers to support India’s COVID-19 pandemic response.
• Abbott says the US Food and Drug Administration has issued an Emergency Use Authorization for its point-of-care coronavirus test, which it claims delivers positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW platform in various healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments.
• Bluebird Bio says it is pushing back to the second half of the year first treatment of commercial patients in Germany with its gene therapy Zynteglo due to the COVID-19 situation. “During this time, Bluebird Bio plans to continue to engage in reimbursement discussions and undertake commercial preparation activities in the priority launch markets in Europe,” it says.
• UK Prime Minister Boris Johnson reveals he has tested positive for coronavirus and will be self-isolating at 10 Downing Street.
• Wuxi Biologics says more than 98% of its staff are now back at work after the country’s recent lockdown. The Chinese CDMO says it has received “a surge of requests” in March for new projects, predominantly from clients outside of China. It adds that the FDA pre-approval inspection of a US Biologics License Application originally scheduled for Q1 2020 has been postponed due to the coronavirus outbreak, “delaying commercial manufacturing revenue for the project.”
• Sanofi and Translate Bio are collaborating to develop a novel mRNA vaccine candidate against COVID-19, extending an existing 2018 agreement between the two firms on mRNA vaccines for infectious diseases. Translate Bio will use its mRNA platform to discover, design, and manufacture SARS-CoV-2 vaccine candidates which Sanofi will provide its external research networks to advance candidates for further development.
• Luxembourg-based API manufacturer C2 Pharma says that in order to meet peaks in demand, it will open access to safety stocks of Digoxin, an API that shows potential to reduce the symptoms of COVID-19 patients in combination with anti-viral drugs. The company is offering samples of Digoxin free of charge to researchers and clinicians working on COVID-19 efficacy trials.
• Denmark’s Novo Nordisk says it will not start any new clinical trials but will continue with ongoing trials and that no significant delays are expected in trials close to finalisation. “All Novo Nordisk manufacturing sites are currently in operation ensuring continued supply of medicine to patients worldwide,” the firm says.
• The proposed merger of Mylan and Pfizer’s generics division, Upjohn, is postponed until the second half of 2020 due to the COVID-19 pandemic. Mylan’s EGM has been pushed back two months to 30 June.
• Thermo Fisher Scientific says its diagnostic test to detect nucleic acid from SARS-CoV-2 has received the European CE mark, an assurance that it complies with the European Union's In vitro Diagnostic Directive.
• A consortium of fifteen biopharma companies have agreed to share their proprietary libraries of drugs that already have promising safety and activity data with the COVID-19 Therapeutics Accelerator launched by the Gates Foundation, Wellcome, and Mastercard to quickly screen them for potential against COVID-19. The firms include BD, Boehringer Ingelheim, bioMerieux, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck & Co., Merck KGaA, Novartis, Pfizer and Sanofi.
• The US Food and Drug Administration warns consumers and health professionals to be cautious of websites and stores selling fraudulent products that claim to prevent, treat or cure COVID-19 and unauthorized test kits. “Do not take any form of chloroquine unless it has been prescribed for you by your health care provider and obtained from legitimate sources,” the agency says.
• Mylan waives its right to a 180-day marketing exclusivity period in the US to distribute its generic version of antiretroviral Kaletra (lopinavir/ritonavir) to help increase the available supply of the product should it prove effective in treating patients with COVID-19.
• Merck & Co. is donating 300,000 masks to New Jersey’s Office of Homeland Security and Preparedness. As of 25 March, New Jersey had more than 3,500 confirmed novel coronavirus cases, the second highest in the US after New York state.
• India’s Directorate General of Foreign Trade bans exports of hydroxychloroquine with immediate effect, just four days after Ipca Laboratories said the US FDA had lifted an import alert on its shipments of the drug. Shipments already ordered or paid for before 25 March can go ahead, says the DGFT. The malaria and arthritis treatment has shown promise in treating patients with COVID-19.
• Medicines for Europe says export restrictions (including some within the EU) on drug and ingredients manufacturers is undermining European production. The generics industry body says its mid-February request for effective coordination between manufacturers and authorities to manage the crisis has not been fully realized. “We deeply regret that this process is not yet fully operational at EU or at national level except in Italy,” it says.
• Gilead asks the US Food and Drug Administration to rescind the orphan drug designation it was granted for its antiviral remdesivir for the treatment of COVID-19. The company was granted the controversial designation in early March; one benefit being a waiver of a lengthy paediatric study plan prior to a New Drug Application. “Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” Gilead says.
• Medical devices industry body AdvaMed writes to the US Federal Emergency Management Agency asking it to oversee centralized distribution of equipment such ventilators, diagnostic tests, protective gear to where they are most needed.
• Vir Biotechnology announces that it has identified multiple human monoclonal antibody (mAb) development candidates that neutralize SARS-CoV-2, the virus responsible for COVID-19. The firm expects human trials to begin within 3-5 months.
• Suven Pharmaceuticals warns customers it cannot export finished products due to a shortage of raw materials following India’s recent lockdown to fight COVID-19. The Indian CDMO says even though Indian pharmaceutical manufacturing is exempted from the lockdown, the shortage had arisen because movement of goods both interstate and intrastate has been halted. “This has…prevented us from being able to export finished products. To compound the situation, the government agencies at the seaports and airports are not operating to inspect and clear those finished goods,” says Suven Pharmaceuticals chairman Venkat Jasti.
• CDMO Catalent reaffirms it has not identified any significant risk or delay that may have a substantial effect on delivery of products or clinical trial supplies.
• AstraZeneca is donating nine million face masks – manufactured and distributed from China -- to support global healthcare workers responding to the COVID-19 pandemic. The company has partnered with the World Economic Forum’s COVID Action Platform, supported by the World Health Organisation, to identify countries in greatest need. Italy will receive the first shipments this week with other countries to follow.
• GE Healthcare and Ford Motor Company are working together to scale and accelerate ventilator production of a simplified version of GE Healthcare’s existing ventilator design to support patients with COVID-19. These ventilators could be produced at a Ford manufacturing site in addition to a GE location.
• Switzerland-headquartered CDMO Siegfried is supplying disinfectant in the Swiss and German regions where it operates production sites. It says it will not supply private or commercial organizations.
• Amid speculation of US insulin shortages, Eli Lilly asserts that its insulin manufacturing sites in the US and Europe remain operational and confirms it does not source APIs for any of its approved medicines from China. The Big Pharma firm says while it has received reports of US pharmacies stating insulin orders are not being fulfilled due to “manufacturer backorder,” it has informed wholesalers and others in the supply chain that it has no products on backorder, including insulin.
• Mesa Biotech receives an Emergency Use Authorization from the US Food and Drug Administration for its Accula SARS-CoV-2 test, which gives point-of-care results in 30 minutes.
• In a letter to customers, CDMO CordenPharma says it has instructed all employees to cancel all business travel and face-to-face meetings until the end of April. It says all its manufacturing facilities in Italy, Germany, France, Switzerland and the US are fully operational.
• CMO Argonaut Manufacturing Services says it is ready to provide services for pre-clinical to Phase III manufacturing of vaccines and therapeutics, including those for firms working toward a COVID-19 vaccine or therapeutic under accelerated timelines.
• The International Generic and Biosimilar medicines Association, representing generic and biosimilar manufacturers, urges governments to reopen air freight routes to ensure access to medicines during the COVID-19 pandemic. “Air freight is a crucial part of the pharmaceutical supply chain. Pharmaceutical manufacturers rely on capacity in passenger flights to ship medicines and ingredients rapidly and securely,” says IGBA chair Hanan Sboul, IGBA chair.
• Amgen is donating USD12.5 million to support global relief efforts to address critical needs in communities impacted by COVID-19. The funds will be used to support emergency response efforts in communities, patient-focused organizations that are mounting their own response efforts, and international relief efforts by Direct Relief and International Medical Corps.
• Roche’s Genentech in collaboration with the Biomedical Advanced Research and Development Authority says the FDA has approved a Phase III clinical trial of its arthritis drug Actemra (tocilizumab) to treat hospitalized adult patients with severe COVID-19 pneumonia. Genentech will also provide 10,000 vials of Actemra to the US Strategic National Stockpile for potential future use.
• Eli Lilly becomes the first Big Pharma company to announce its clinical trials are being adversely affected by coronavirus. The firm says it is delaying most new study starts and pausing enrollment of new patients or volunteers “to ease the burden on participating healthcare facilities.”
• The US Food and Drug Administration issues new guidance saying it won’t take action against sponsors and others for the duration of the coronavirus emergency for failing to adhere to Risk Evaluation and Mitigation Strategy requirements for certain laboratory testing or imaging studies.
• Eli Lilly says it is expanding its partnership with the Indiana State Department of Health to offer free drive-through coronavirus testing to Indianapolis area healthcare workers starting 23 March.
• Merck & Co. says it has delivered 500,000 personal protective masks to New York City Emergency Management to help fight the outbreak in New York. As of 21 March, New York State has more than 10,000 confirmed coronavirus cases.
• Gilead says it is no longer accepting requests for emergency access to its antiviral remdesivir due to an “exponential increase” in such requests and “overwhelming demand.” The experimental drug is being tested as a treatment for patients with COVID-19.
• The Indian government approves a USD1.8 billion scheme to boost production of APIs and medical devices. The plan involves development of three mega API drug parks in partnership with states and financial incentives to manufacturers of 53 identified critical APIs on incremental sales for the next six years.
• In a filing to the Bombay Stock Exchange, Ipca Laboratories says the US FDA has lifted an import alert on its hydroxychloroquine sulphate and chloroquine phosphate APls and hydroxychloroquine sulphate tablets due to the shortage implications of coronavirus.
• Bristol Myers Squibb says it has now implemented a mandatory work from home policy for its workforce. “All employees, contingent workers and contractors who can do their jobs from home must do so,” it says.
• Bristol Myers Squibb says it will not initiate or activate any sites globally for new clinical trials until April 13 and warns the timeframe could extend beyond this date.
• Following similar moves by Mylan and Teva to increase availability of hydroxychloroquine, Novartis promises to donate up to 130 million doses by the end of May – pending regulatory approval -- to support the global COVID-19 response. The company is also exploring further scaling of capacity to increase supply.
• The US Food and Drug Administration allows manufacturers of devices that measure vital signs such as body temperature, respiratory rate, heart rate and blood pressure to expand their use so that health care providers can use them to monitor patients remotely. “Such devices include technologies capable of enabling remote interactions to provide crucial information to be used as an adjunctive when health care providers diagnose or treat COVID-19,” the regulator says.
• US industry bodies, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) say the country’s biopharmaceutical companies “are working around the clock” to increase COVID-19 testing capability and capacity, screen medicines libraries to identify potential treatments and initiate clinical trials, research and develop new therapies and treatments and use investments in new technologies to speed vaccines development.
• Teva says it is donating more than 6 million doses of hydroxychloroquine sulfate tablets through wholesalers to US hospitals by March 31 to treat COVID-19. Additional production of hydroxychloroquine sulfate tablets is being assessed and Teva is aiming to ship more than 10 million within a month.
• To reduce Indian reliance on API imports, the Confederation of Indian Industry asks the Indian Government to declare API as a strategic sector and suggests that firms with 40% capacity utilization should be allowed to manufacture APIs which are being imported. It also proposes the creation of large API parks with fiscal benefits for existing API and intermediates plants and boosting drug formulations from indigenous APIs and their intermediates.
• The US Food and Drug Administration grants Bellerophon Therapeutics emergency expanded access for its proprietary inhaled nitric oxide delivery system, INOpulse, to be used for the treatment of COVID-19.
• The number of deaths in Italy from COVID-19 increases to 3,405 exceeding that of China. For the first time, China reports no new domestic cases.
• Australian biotech CSL donates its proprietary adjuvant technology, MF59, to the University of Queensland’s pre-clinical COVID-19 vaccine development program.
• Bayer donates 3 million tablets of its malaria drug Resochin to the US government, saying limited clinical research in China has shown its potential in treating patients with COVID-19. It says it is working on an Emergency Use Authorization for the drug’s use in the US.
• Mylan says it has restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility as the malaria and arthritis drug shows potential in treating COVID-19. The generics firm says it expects to start supplying product by mid-April, and based on current API stocks, will be able to ramp up manufacturing to 50 million tablets.
• Merck KGaA says it has donated a supply of its MS drug Rebif to the French Institut National de la Santé et de la Recherche Médicale for use in a clinical trial for patients with COVID-19.
• The US Food and Drug Administration issues guidance for pharma companies, investigators and institutional review boards facing challenges conducting clinical trials during the coronavirus pandemic. It recommends sponsors evaluate alternative methods for assessments such as phone contacts or virtual visits and offer additional safety monitoring for trial participants without access to investigational products or the investigational site.
• CDMO Oxford Biomedica implements a daily senior management working group to monitor current COVID-19 developments and UK government guidance to risk assess its supply chain and to direct its phased response. OXB says it “has not experienced any and does not currently expect to experience significant supply issues or any changes in customer demand.”
• Eli Lilly partners with the Indiana State Department of Health (ISDH) in a US Food and Drug Administration-supported scheme to accelerate testing in Indiana for coronavirus. Lilly will use its laboratories to analyse samples taken in Indiana healthcare facilities, including nursing homes and emergency rooms.
• In a letter to customers, CDMO Bora Pharmaceuticals says “to manage the risk to production and supplies, we are continuing to monitor our supply chains to assess stock levels.” It adds that although the situation is currently under control, “we will maintain certain stocks and ensure the stability of our supply chain remains intact.”
• Catalent says it has established a senior, multi-disciplinary coronavirus response team to monitor the global situation and execute mitigation activities. The CDMO says it has not identified any significant risk that threatens delivery of products or clinical trial supplies and it has “adopted specific procedures to minimize and manage any future disruption to our ongoing operations.” These include expanded safety stocks of raw materials and personal protective equipment, as well as ongoing monitoring of suppliers’ stock levels to assure future deliveries.
• AbbVie and Allergan’s USD63 billion merger could be delayed after the US Department of Justice's antitrust division warned it may struggle to complete merger reviews in time due to COVID-19.
• In an update, Sanofi says its global network of manufacturing plants is operational and the diversity of its global sourcing is helping ensure business continuity across all product lines. “At this time, Sanofi does not anticipate shortages for patients resulting from the COVID-19 situation,” the French pharma firm says.
• The World Health Organization says South-East Asian countries need to urgently scale-up aggressive measures to combat COVID-19, as confirmed cases cross 480. “The situation is evolving rapidly. We need to immediately scale up all efforts to prevent the virus from infecting more people,” says Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region.
• Medicines for Europe says blocks at Italy’s borders with Austria and Switzerland are delaying trucks carrying supplies for medicines production and finished medicines that, if unsolved, puts Europe at risk. “These blockages are caused by different rules being applied by Interior Ministries and Transport ministries in the same country!” the generics industry body says.
• Novartis announces measures to support the global response to COVID-19, including the creation of a global fund to support communities impacted by the pandemic as well as its decision to join two cross-industry R&D initiatives.
The Novartis COVID-19 Response Fund will provide USD 20 million in grants to support public health initiatives designed to help communities manage challenges posed by the pandemic. An accelerated global review process will approve individual grants of up to USD 1 million.
Novartis says it has joined the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative (IMI).
• Pfizer and BioNTech sign letter of intent to co-develop and distribute the latter’s potential COVID-19 vaccine, BNT162, globally (excluding China). The collaboration aims to accelerate development of the vaccine programme, which should enter clinical testing by the end of April.
• Merck KGaA postpones its Annual General Meeting scheduled for April 24 in Frankfurt am Main, Germany, to a later date due to the coronavirus pandemic.
• Johnson & Johnson says there is lack of evidence to suggest its HIV drug darunavir (DRV) can effectively treat COVID-19, citing “anecdotal, unsubstantiated reports” to the contrary.
• Biotech firm Moderna says the first patient has been dosed in a Phase I clinical trial of its mRNA vaccine against coronavirus at the US National Institutes of Health.
• Sanofi and Regeneron announce they are ready to start a multi-centre, double-blind, Phase 2/3 trial of their novel interleukin (IL)-6 receptor inhibitor Kevzara in patients hospitalised with severe COVID-19. The first part will recruit patients with severe COVID-19 infection across around 16 US sites and will evaluate the impact of Kevzara on fever and patients' need for supplemental oxygen. The second, larger part of the trial will evaluate the improvement in longer-term outcomes including preventing death and reducing the need for ventilation, supplemental oxygen and/or hospitalization.
• Armas Pharmaceuticals says it does not expect any COVID-19-related product disruptions. The generics firm says it is closely monitoring stock levels at its logistics provider and is in contact with supply chain partners, group purchasing organizations, wholesalers and distributors to oversee where it can assist in ensuring supply of its products.
• BioNTech says it has partnered with Fosun Pharma to develop the former’s potential COVID-19 vaccine BNT162 in China. Fosun Pharma will commercialize the vaccine in China upon regulatory approval, with BioNTech retaining full rights to develop and commercialize the vaccine in the rest of the world.
• Biopharma firm Amarin says it has suspended all of its sales force's face-to-face activities for its lead product, Vascepa, until 30 March to help reduce the spread of COVID-19.
• The US Centers for Disease Control and Prevention recommends that for the next 8 weeks, organizers of mass gatherings of 50 people or more cancel or postpone them.
• Medicines for Europe calls for “maximum, pan-European collaboration and coordination to succeed and limit the pandemic” and warns that the crisis “cannot hinge on national protectionism which could block the circulation of essential medicines.”
The generics industry association highlights three urgent actions to ensure Europe-wide supply of medicines:
1) All available Europe pharmaceutical manufacturing should be open and running at all times, avoidance of export restrictions on manufacturers of medicines or APIS and the creation of green lanes for the flow of medicines and ingredients across national borders.
2) Clear regulatory guidance to counter the stress on global supply chain made by production and logistics problems.
3) Analysis of the scenarios of the possible future spread of coronavirus to plan for possible future surges in demand.
• Thermo Fisher Scientific says the US Food and Drug Administration has issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the US to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.
• Novartis requests all employees in Europe, the US and Canada to work from home for the next three weeks effective Monday, 16 March, except for those working in laboratories, manufacturing sites and in the field.
• Pfizer promises to make available its manufacturing capabilities for approved therapies or vaccines for COVID-19 that need to be rapidly scaled and deployed. “As one of the largest manufacturers of vaccines and therapeutics, Pfizer is committed to using any excess manufacturing capacity and to potentially shifting production to support others in rapidly getting these life-saving breakthroughs into the hands of patients as quickly as possible,” the pharma company says.
• Describing its medicines supply chain as “robust,” AstraZeneca says it has implemented temporary measures to help reduce the risk of COVID-19 infection. “These include leveraging digital technology to support working-from-home, as well as restricting business travel, off-site meetings and external visitors to AstraZeneca sites,” it says.
On the research side, AstraZeneca says it has rapidly mobilised research efforts to discovering novel coronavirus-neutralising antibodies as a treatment to prevent COVID-19: “Our teams are now focused on identifying monoclonal antibodies to progress into clinical trial evaluation.”
• The US Food and Drug Administration says it has granted an Emergency Use Authorization (EUA) for Roche’s cobas SARS-CoV-2 Test within 24 hours of receiving the application. The EUA is the third granted for a diagnostic test during the COVID-19 outbreak.
• AbCellera and Eli Lilly agree to co-develop antibody products derived from blood samples from one of the first US patients who recovered from COVID-19, for the treatment and prevention of the disease.
• CDMO Catalent says it has not identified any significant COVID-19-related risk to its supply chain that may have a substantial effect on delivery of any product or clinical trial supplies. It says all sites are fully operational and it has established a dedicated senior leadership team and specific procedures “to assure that we minimize and manage any future disruption to our ongoing operations for the continued supply of clinical and commercial materials, products, and services.”
• Indian pharmaceutical supply chain disruption could be far greater than the China environmental regulation-induced shortfall of 2017 If the COVID-19 outbreak is not contained within the next three months, says credit ratings agency India Ratings and Research.
• The COVID-19 death toll in Italy surpasses 1,000, with 189 new fatalities in just over two weeks, the Italian government announces.
• Informa announces CPhI North America 2020, originally scheduled on 5-7 May, has been postponed to 9-11 September. The exhibition will still take place at the Pennsylvania Convention Center in Philadelphia.
• The Asian Development Bank says it will make available USD 200 million through its supply chain finance program for companies manufacturing and distributing medicines and other items to combat COVID-19.
• Bristol Myers Squibb says it is strongly encouraging its global workforce, including employees, contingent workers and contractors, to work remotely if they can, effective 13 March. The pharma company has also expanded restrictions on visitors to its sites and in-person meetings.
• Vir Biotechnology and Biogen sign a letter of intent for the development and manufacturing of human monoclonal antibodies for the potential treatment of COVID-19. Because of the urgency of the situation, the companies say they have begun work while a definitive agreement is being negotiated. Biogen would continue cell line development, process development, and clinical manufacturing activities in order to advance the development of Vir’s proprietary antibodies.
• Genentech says two people who were at its South San Francisco campus on 2 March have since tested positive for COVID-19. The biotech firm says it is encouraging employees to work from home where possible, restricting global and domestic company air travel and cancelling or postponing large meetings.
• India’s Ministry of Environment, Forests and Climate Change says to ensure drug availability to reduce the impact of the COVID-19 outbreak, it will expedite environmental clearances for bulk drug projects -- including API and intermediate production -- within the country.
• In a COVID-19 update, GE Healthcare Life Sciences says it is experiencing “limited disruptions from suppliers and transport is becoming increasingly challenging.” The CDMO says it is holding daily cross-functional call with its logistics, customer service and sales & operations planning to review shipments. It says it is moving materials to regional warehouses 10-14 days earlier than normal to mitigate potential delays caused by flight cancellations. “At this time, we are not experiencing delays or impact to our manufacturing capabilities,” it says.
• CDMO WuXi AppTec says its Wuhan site has resumed operations, in compliance with local regulations and global COVID-19 health and safety guidelines. Operations at the facility, which provides discovery chemistry services, will ramp up over the coming days and weeks.
• US President Donald Trump announces travel restrictions from Europe to the US on foreign nationals who have travelled to any of the 26 European countries in the Schengen Area in the past 14 days before coming to the US, effective midnight 13 March.
• Italy’s prime minister Giuseppe Conte announces a closure of all ‘non-essential’ shops except supermarkets and pharmacies as reported cases of COVID-19 in the country top 12,000.
• Lilly confirms that an employee in Indianapolis has tested positive for COVID-19.
• Declaring COVID-19 a pandemic, the World Health Organisation is “deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction,” says director-general Dr Tedros Ghebreyesus.
• Biotech firm Tiziana Life Sciences says it is expediting development of its anti-interleukin-6-receptor mAb, TZLS-501, for treatment of patients infected with COVID-19. An excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness, it says.
• Novartis is the latest pharma company to say it does not anticipate supply chain disruption at the present time. “Where required, we have enacted mitigation plans to ensure ongoing drug supply to depots for our clinical studies, and we are working closely with the authorities on dispensing to trial participants,” it says.
The Swiss firm says that as well as evaluating existing products to see if any could be repurposed, it will make available from its libraries a set of compounds that it considers suitable for in vitro antiviral testing, in response to the European Federation of Pharmaceutical Industries and Association’s urgent call for R&D on coronavirus.
• The number of reported COVID-19 cases in the US rises to 1,312, with 38 deaths.
• Several bodies representing Italy’s pharmaceutical supply chain, including industry associations Farmindustria and Federfarma say “the seriousness of the [COVID-19] situation requires us to guarantee, as always, our maximum commitment in the production and distribution of medicines to the nation.”
• The US Food and Drug Administration postpones “most foreign inspections” through April in response to the COVID-19 outbreak. Inspections outside the US deemed mission-critical will be considered on a case-by-case basis, it says. The regulator had already suspended on-the-ground inspections in China, the source of the outbreak, but the new restrictions will include India, a key supplier of active pharmaceutical ingredients (APIs) and generic medicines.
• Generics firm Teva says it is taking measures to ensure the reliability of its global supply chain and identifying opportunities for its pharma and API businesses to address potential shortages in affected markets. It says the only impact so far on its API network is the closure of one small API site in China, with preparations for restart progressing.
• Roche asks all of its 1,200 Spanish employees to work remotely as of Wednesday amid the COVID-19 outbreak. “The company will maintain its normal activity and will guarantee, as until now, the supply of medicines to hospitals,” the Swiss firm says. The number of reported cases in Spain has risen to 1,646 as of Tuesday, with 28 deaths.
• The European Medicines Agency says it is closely monitoring the potential impact of the COVID-19 outbreak on pharmaceutical supply chains into the EU. While no shortages or supply disruptions of medicines marketed in the EU due to COVID-19 have been reported, it says that as the public health emergency develops, shortages or disruptions “cannot be excluded.”
Along with the European Commission and member state national competent authorities, the EMA has organised the first meeting of the EU Executive Steering Group on medicine shortages caused by major events to discuss measures aimed at addressing the impact of COVID-19 on EU medicines supply.
The group will identify and coordinate EU-wide actions when medicines are at risk of supply shortage due to a temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment.
The EMA also highlights “the responsibility of pharmaceutical companies to ensure the continuity of supply of their medicines,” with manufacturers expected to put in place appropriate resilience measures such as the increase of stocks or dual sourcing of products and materials.
• The Indian Pharmaceutical Alliance and the Indian Drug Manufacturers’ Association write to the Indian government, asking it to reverse restrictions on API exports, claiming they have surplus stock to deal with any shortages.
• As Italy’s reported cases of COVID-19 top 10,000 and the death toll rises from 366 to 463 Monday, the government extends emergency measures – including travel restrictions and bans on public gatherings – to the entire country.
• Vertex Pharmaceuticals says the coronavirus outbreak has not had any impact on its supply chain. “We are well-prepared from a business continuity perspective, with ample supply to meet commercial needs well into the future,” says CEO Jeffrey Leiden.
• The Bill & Melinda Gates Foundation and charities Wellcome Trust and Mastercard Impact fund pledge up to USD 125 million on an initiative to help development of treatments for coronavirus. The COVID-19 Therapeutics Accelerator will first focus on testing antiviral drugs that have already gone through preclinical development.
• In an internal memo, Lilly asks US employees to work from home if possible, to reduce the risk of transmission to workers using specialised equipment in manufacturing facilities and R&D labs who do not have the option of working from home.
•Swedish CDMO Recipharm says it expects some of its facilities in the restricted zone of northern Italy to operate at a lower capacity than normal over the coming days but stresses that currently, they continue to “receive materials, manufacture and deliver routinely.”
• Innovation Pharmaceuticals says its defensin mimetic candidate, Brilacidin, has been shipped to one of the US’s regional biocontainment labs for testing against coronavirus.
• As the global number of confirmed COVID-19 cases surpasses 100,000, the WHO says the spread of the virus can be significantly slowed or even reversed through the implementation of robust containment and control activities such as identifying sick people, bringing them to care following up on contacts, preparing hospitals to manage a surge in patients, and training health workers.
• The South Korean Ministry of Food and Drug Safety approves phase II clinical trial of Gilead’s remdesivir on 100 hospitalised COVID-19 patients.
• Biogen says all attendees of a recent employee meeting in Boston have been directed to work from home for two weeks after three of them tested positive for COVID-19. The biotech firm said it is also restricting business travel through the end of March.
• Amgen says it has suspended international business travel and attendance at medical congresses, conferences and other large events until 17 April. Based on current inventory levels, the firm says it does not anticipate a shortage of its medicines.
• South Korean CDMO Samsung Biologics confirms that to date, no employees at its Songdo facility have been diagnosed with COVID-19. It says it is conducting daily assessments of the potential impact on its supply chain and business activities.
• India’s Minister of Chemicals and Fertilizers, DV Sadananda Gowda says API stocks are sufficient for another three months of manufacturing. Minister of State for Chemicals and Fertilizers, Mansukh Mandaviya is leading a task force to look at increasing Indian API production.
• Mairead McGuinness, first vice-president of the European Parliament says MEPs will debate the potential shortage of medicines in Europe on 11 March, given the increasing strain on global public health services and pharmaceutical supply chains due to the spread of coronavirus.
• Quest Diagnostics says it will be in a position to receive specimens and start conducting a test for coronavirus for US patients by next Monday (9 March), pending review by the FDA under emergency use authorization.
• Merck KGaA says it is difficult to determine the potential impact of coronavirus on general economic developments and its own business and it has developed various scenarios. “According to the scenario being applied right now, the epidemic will reach its high point in the first quarter and subside in the course of the second quarter,” before normalizing in H2, the company says, adding that based on these assumptions, it would expect a negative effect of -1% on 2020 net sales. “Should the crisis grow or trigger a global recession, the company would adapt its business forecast,” Merck KGaA concludes.
• Xinhua News, China’s official state-run news agency, posts an article saying that if China bans exports of pharmaceutical products to the US, the US will be “plunged into the mighty sea of coronavirus.”
• Dr. Julie Gerberding, executive vice president at Merck & Co. and former director of the US Centers for Disease Control and Prevention cautions people “not to overpromise on the timeline of the vaccine availability” citing longer clinical development and more difficult manufacturing.
• Vir Biotechnology and Alnylam Pharmaceuticals expand their existing collaboration to include the development and commercialisation of RNAi (RNA interference) therapeutics targeting SARS-COV-2, the virus that causes COVID-19.
• China’s National Health Commission updates treatments guidelines saying Roche’s rheumatoid arthritis drug, Actemra (tocilizumab) can be used to treat some coronavirus patients with serious lung damage from uncontrolled immune response.
• Japan’s Takeda Pharma says it is developing a plasma-derived hyperimmune globulin therapy (TAK-888) to treat high-risk patients with COVID-19 and will share its plans with US Congress members. It is also exploring whether its currently marketed and pipeline products could be viable candidates for the treatment of COVID-19.
• Total reported cases of COVID-19: 92,943 and 3,160 deaths: WHO.
• Inovio Pharmaceuticals announces an accelerated timeline for developing its DNA vaccine INO-4800 to address COVID-19. The company plans to begin human clinical trials in the US in April and then in China and South Korea. It plans to deliver one million doses by year-end based on existing resources and capacity.
• Amid concern about the impact of coronavirus, major drug maker Lilly says it does not anticipate shortages for any of its products, including all forms of insulin. It says it does not source APIs for any of its approved medicines from China, while its insulin manufacturing sites in the US and Europe have not been affected by coronavirus.
• India restricts exports of 26 APIs including antibiotics, vitamins and hormones with immediate effect, according to a Directorate General of Foreign Trade notification. The move is understood to ensure no shortages of drugs as a result of China’s current lockdown.
• World Health Organisation director-general Dr Tedros Ghebreyesus says containment of COVID-19 is “feasible and must remain the top priority for all countries.”
• China reports 206 cases of COVID-19 over the last 24 hours, the lowest since 22 January, according to the WHO.
• Outside China, 8,739 cases reported from 61 countries, with 127 deaths: WHO.
• US President Donald Trump meets with pharmaceutical executives at the White House, wanting to hear about progress on therapies and vaccines for COVID-19. According to latest estimates, a vaccine is 12-18 months away, while a therapeutic treatment could be developed within months.
• Sun Pharma says there is a shortage of APIs for its generic hypertension drug, pindolol, brand name Visken, in the US but that it was not due to the Chinese situation.
• Bristol Myers Squibb says it has restricted employee business travel globally and is monitoring manufacturing and supply facilities across the globe. “At this time we do not anticipate disruptions to the supply of our medicines for patients due to COVID-19,” it says.
• China reports 329 cases in last 24 hours – the lowest in more than a month, according to the WHO.
• China reported cases: 78,959 cases and 2,791 deaths: WHO.
• Outside China, 4,351 cases in 49 countries, and 67 deaths: WHO.
• The US Food and Drug Administration reports the first case of a pharmaceutical drug shortage directly related to the global coronavirus (COVID-19) outbreak. In a supply chain update, the agency’s commissioner of food and drugs, Stephen Hahn says a manufacturer has alerted the FDA to an unnamed human drug that has recently been added to the drugs shortages list due to an API shortage caused by a site affected by coronavirus.
• In an earnings call, Mylan president Rajiv Malik says the firm has alternative arrangements for API supply and does not see any immediate coronavirus impact, unless the situation persists for another few months.
• Sandoz commits to keep prices stable of certain essential medicines it markets that may help in the treatment of COVID-19 cases “despite current uncertainties about how the supply situation will evolve.” Novartis’ generics subsidiary singles out antivirals to reduce the impact of coronavirus and antibiotics to combat pneumonia.
• In an SEC filing, Merck & Co warns that “the outbreak of the virus has caused material disruptions to the Chinese economy, including its health care system, which will have a negative effect on the company’s first quarter 2020 results which, at this time, is not expected to be material." Merck adds that the outbreak of COVID-19 has so far had a limited effect on its supply chain of drugs into and raw materials out of China.
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