UPDATED: COVID-19 PHARMA TRACKER6 Apr 2020
The latest coronavirus updates and developments impacting the global pharmaceutical supply chain…
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• 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.
• 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.
Find more statistics at Statista
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