Biopharma News
Biopharma news
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News Clinical knowledge deficits to slow biotech development, warns Europital
The CRO predicts investment communities will come to the rescue of small and medium companies looking to advance their candidates -
News Argonaut Manufacturing Services opens custom controls & standards facility
The CMO has designed the new service to alleviate manufacturing challenges associated with positive controls and nucleic acid templates -
News Almac expands global biologics testing services with mass spectrometry investment
The company's £0.5 million investment in mass spectrometry support accelerates biologics development and approval -
News EU delivers export threat after AstraZeneca cuts Q1 vaccine supply
European Commission pressures pharma firm over reduced shipments amid criticism for slow vaccine rollout across block -
News Emergent to manufacture Humanigen COVID-19 therapeutic
The CDMO gears up for rapid deployment of its clinical-to-commercial manufacturing operations for its seventh collaboration to help deliver COVID-19 treatments -
News Sartorius and RoosterBio partner to advance scale-up of hMSC manufacturing
The collaboration aims to accelerate the development and commercialization of groundbreaking cell-based regenerative cures -
News Thermo Fisher buys Novasep viral vector manufacturing business
Expanded global capacity addresses growing demand for cell and gene therapy -
News Merck KGaA expands its mRNA capabilities through AmpTec acquisition
AmpTec's differentiated PCR-based technology has shown to have advantages compared with other technologies for mRNA manufacturing -
News Baxter BioPharma Solutions to manufacture Novavax COVID-19 vaccine
Manufacturing at Baxter's Halle/Westfalen, Germany facility will help increase commercial production and promote access in UK and European markets -
News Abzena to open new biologics GMP manufacturing site in the US
The new facility will house up to 12 X 2000-L bioreactors and will be equipped to handle existing and new advances in manufacturing -
News Bavarian Nordic to supply smallpox vaccines to three European countries
The company hopes its newly built fill and finish facility will assume commercial manufacturing this year -
News Fujifilm Diosynth Biotechnologies to establish new viral vector manufacturing facility in Boston
The $40 million investment marks the company's third viral vector manufacturing site -
News AGC Biologics becomes first manufacturer of newly approved Libmeldy
The CDMO will use its gene and cell therapy commercial expertise to bring "remarkable innovation" to young eligible patients -
News Wuxi agrees €150 million deal to buy Wuppertal drug substance facility from Bayer
Acquisition will extend the Chinese CDMO’s European footprint and will complement Leverkusen drug product site -
News Lonza to expand bioconjugation capabilities at Visp site
CDMO will add two production suites for clinical and commercial supply and extend lab space to double analytical and process development capacity -
News Spanish CDMO Reig Jofre to manufacture Janssen COVID-19 vaccine candidate
The company will be responsible for the formulation, filling, and packaging of Ad26.COV2-S at its new €30 million injectable products plant in Barcelona -
News Thermo Fisher boosts clinical supply chain and distribution services in Europe
Two new facilities in Germany will provide clinical supply and cold chain services to support growing demand -
News Lilly nabs gene therapy company Prevail Therapeutics
Through the acquisition, Lilly will establish a gene therapy program via Prevail's gain clinical-stage and preclinical neuroscience assets -
News AstraZeneca taps Halix for commercial drug substance manufacture of COVID-19 vaccine
Dutch CDMO will expand with two additional viral vector production lines to meet the increased demand -
News Catalent starts manufacture of Passage Bio's lead gene therapy products
The CDMO will provide packaging, labeling and distribution services through its FastChain demand-led supply offering -
News CPHI Online Report - Pharma Market Trends 2021
Twelve pharma market trends we anticipate across 2021 for the drug development, manufacturing and outsourcing sectors. -
News AZ and Oxford COVID-19 vaccine brings end of pandemic a little closer
AZD1222 is 90% effective, cheap to produce and easy to store, distribute and administer -
News Alvotech and Yangtze River forge biosimilar deal for Chinese market
The partnership will focus on commercializing eight biosimilar medicines in China for the domestic market -
News Early trial results hail Moderna's COVID-19 vaccine as 94.5% effective
Data also show that mRNA-1273 remains stable at 2–8°, the temperature of a standard home or medical refrigerator, for 30 days. -
News Seqirus to build $800m influenza vaccine manufacturing facility in Australia
The facility will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere. -
News European Commission wraps up CureVac COVID-19 vaccine supply deal
Europeans set to benefit from the EC's authorization of COVID-19 candidate vaccine supply agreement, securing up to 405 million doses of CVnCoV -
News Vibalogics establishes US presence with virotherapy facility in Boston
The specialist CDMO's $150 million 3-year investment plan will provide a complete suite of virotherapy services to support drug developers and their most "revolutionary" products. -
News Pharmapack Podcast: The opportunities and challenges of bringing connected devices to market in the drug delivery sector
Smart, connected devices are revolutionizing drug delivery in the ways they can gather, order and transmit crucial patient data to physicians -
News Who are BioNTech?
CPHI lifts the lid on the relatively little known German biotech and partner of Pfizer behind the most promising COVID19 vaccine candidate -
News Biomanufacturing: a future shaped by evolving markets, technology and global events
Gareth Macdonald
The coronavirus pandemic has impacted biopharmaceutical manufacturing and is likely to continue to do so for years to come. But the pandemic is not the only thing changing how the industry goes about making medicines. -
News Stelis starts next phase of investment into its biologics manufacturing facility
This phase sees the CDMO start work on installing two 2,000-L single-use bioreactor trains in its mammalian cGMP facility. -
News Pfizer and BioNTech COVID vaccine proves 90% effective
Results from a Phase III clinical study found Pfizer and BioNTech's mRNA-based vaccine candidate, BNT162b2, is more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection, the companies announced Monday... -
News Altimmune signs up Lonza to manufacture intranasal COVID-19 vaccine
Altimmune adds Lonza as a manufacturing partner for supply of AdCOVID, its single-dose intranasal vaccine candidate for COVID-19. -
News It’s time for the pharmaceutical sector to do the smart thing
For many years, well before the arrival of COVID-19, the pharmaceutical sector has faced increasing pressures, with challenges such as fake goods and grey market diversion. There is also increased emphasis on how to ensure patient adherence, as this di... -
News The challenges of innovating in packaging and drug delivery
In this interview with Pharmapack, Arnaud Steiner, R&D Packaging Manager at Virbac shares his thoughts on trending issues in the packaging market such as patient centricity and eco-design, the challenges of managing the development of new packaging and... -
News Nostrum Laboratories recalls lots of metformin tablets after nitrosamine detection
Company is the latest in a lengthening list of pharma companies recalling the diabetes medicine over unacceptable levels of NDMA -
News Minaris Regenerative Medicine to expand its cell & gene therapy manufacturing capacity
The expansion will entail building two new facilities - one in Germany, the other in Japan. -
News Sanofi and GSK to support COVAX with 200 million doses of COVID-19 vaccine
The companies anticipate first results of Phase I/II in early December 2020, to support the initiation of a pivotal Phase III study before the end of the year. -
News Russia submits Sputnik V emergency use and prequalification application to WHO
The Russian Federation has become one of the first countries to apply to the WHO for prequalification of its vaccine, Sputnik V, against the novel coronavirus infection. -
News Vaccine manufacturing demand has had limited effect on regenerative medicine sector, panel tells CPHI audience
The ramping up of vaccine manufacturing demand amid the COVID-19 pandemic had an initial impact on cell and gene therapy production but the regenerative medicine sector has largely weathered the storm, according to senior industry figures in a recent p... -
News The future of bacterial manufacturing is now
By Duncan Emerton, PhD; Director, Custom Intelligence, Informa Pharma Intelligence -
News RedHill Biopharma secures expanded manufacturing for COVID-19 therapeutic candidate
The biopharma company collaborates with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing. -
News Synthesis Theta
The recipe for efficiency by Universal Pack -
News Company Profile
MPA Technical Devices Srl is an Italian company specializing in designing and manufacturing top quality and accurate dosing systems. -
News Company introduction – Cyclolab Cyclodextrin Research and Development Ltd
CycloLab Cyclodextrin Research and Development Ltd. is a private SME with the focus on cyclodextrin research and development for over 30 years. We are working in the fields of pharmaceutical, cosmetic and food industry, agrochemical, environmental and ... -
News Streamlining biologics and biosimilars drug development process through a single source
The increasing number of complex and sensitive biologics and the administration shift from hospitals to patients' homes are two of today’s main biopharmaceutical industry challenges. Complex drugs and self-administration require an appropriat... -
News Biologics & biosimilars: Drug delivery innovation is finally here
Pushpa Vijayaraghavan Director, Healthcare & Lifesciences Practice, Sathguru Management Consultants -
News Trends in autoinjectors and pre-filled syringes
The rise of specialty and biologics has meant that one of the fastest growing segments by value today are Injectables demonstrating a 5-Year CAGR of 10%. This growth of course has implications and creates pressures across various areas such as treatmen... -
News Biosimilars as market drivers for autoinjector technology
Charbel Tengroth, Managing Director, Tengroth Consulting -
News CPHI Festival of Pharma Blog
With the Festival of Pharma now well and truly upon us, keep abreast of all that is happening and when over the ten days of this vast virtual event. -
News Patient-centric medicines the way forward during COVID-19 crisis, say CPHI panel
Festival of Pharma roundtable discusses how drug delivery formulation and development is focused on hospital-to-home care setting -
News Abzena invests $60m into cGMP manufacturing capacity
The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects. -
News MHRA approves second of two GMP manufacturing suites for COVID-19 vaccine candidate
The two suites, established with VMIC equipment and operated by Oxford Biomedica, will be operating at 1000-L scale. -
News HPNE introduces defined tubing routing for single-use facilities
Flexible support system simplifies and secures tubing paths for biopharmaceutical manufacturers. -
News Purification specialist BIA Separations to become part of Sartorius
BIA Separations will be Sartorius's center of excellence for purification of cell and gene therapeutics. -
News Cobra Biologics to manufacture plasmids for COVID-19 vaccine trial
Scancell’s DNA vaccine could provide long-lasting immunity against COVID-19 by generating protection against this and new strains of coronavirus. -
News Novel customizable and flexible single-use assembly solution
Hugh Purity New England's solution can utilize other vendors' components and can be implemented directly into any process. -
News New thin film technology to revolutionize vaccine storage and distribution
Up to 500 doses of vaccine to be placed on a single wafer-thin and stored for extended periods of time. -
News Ingredients and Formulation - evolving opportunities and challenges
Ingredients are the lifeblood of the pharmaceutical and nutraceutical industries. They connect today’s cutting-edge medicine and consumer products makers with their origins in the chemicals sector of the late nineteenth century. While ingredients... -
News Alvotech and DKSH extend biosimilar partnership in Asia
The companies will commercialize six new biosimilar candidates addressing multiple therapeutic areas. -
News Micreos initiates trial to evaluate world's first endolysin-drug as a therapy for atopic dermatitis
The targeted removal of one particular bacterial species from the skin microbiome, while preserving the beneficial ones, represents a new way to treat atopic dermatitis. -
News Tackling Issue of Pharmaceuticals in the Environment from Manufacturing Emissions
The second in a quarterly series of blog posts about responsible supply chain management from the PSCI Chair, Caroline O'Brien -
News T-knife and Catalent sign tech transfer and manufacturing agreement
Catalent to manufacture clinical batches of T-knife's platform process for TCR-based cell therapy at its site in Gosselies, Belgium, for European trials in 2021. -
News TESSA technology for robust and reproducible AAV manufacture at scale
Novel, plasmid-free manufacturing system reduces the cost of goods and improves AAV quality to enable development of safer gene therapies. -
News Humanigen and Lonza collaborate to expand manufacturing of COVID-19 therapeutic candidate
Humanigen's proprietary monoclonal antibody may prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19. -
News Univercells Technologies introduces new upstream platform for virus manufacturing
The NevoLine Upstream platform has been designed to address the needs of gene therapy and vaccine innovators and CDMOs for robust and cost-effective upstream viral vectors manufacturing. -
News Pharmapack 2021 opens entries for Patient-Centric Design Awards
The global pandemic continues to impact lots of industries and slow down business, but the pharma and packaging industries are striving to tackle new challenges to bring more faster and safer solutions to deliver medication to patients. The Pharmapack ... -
News The latest patient-centric packaging & drug delivery solutions revealed in Pharmapack 2020 Innovation Gallery
Pharmapack Europe, the leading conference & exhibition in pharma packaging & drug delivery business traded the successful 2020 edition at the beginning of February. The innovation gallery, as the key feature of this event, has gathered the most recent ... -
News More than just wrapping a pill: improving patients’ lives through packaging
There is a great focus on medical packaging as a means of protecting the drug, but there is still a long way to go when talking about the real needs of patients, and what packaging can do for them. For the past six years, Giana Carli Lorenzini,Postdoct... -
News Mylan to acquire Aspen's thrombosis business in Europe
The transaction will further complement and expand Mylan's complex injectables offering and presence in hospitals. -
News Exelixis and Catalent collaborate to develop antibody-drug conjugates
The partnership will focus on developing multiple ADCs using Catalent’s proprietary SMARTag site-specific bioconjugation technology. -
News Mylan and Biocon Biologics launch Lantus biosimilar in the US
Semglee available in vial and pen presentations at a 65% discounted list price, the lowest available for a long-acting insulin glargine on the market. -
News Pfizer sells biologics manufacturing facility in Adelaide
Bridgewest to develop the site into a full-service contract development and manufacturing organization. -
News Oral Solid Dose Regulatory Hurdles and How to Approach Them
In your quest to meet the regulatory requirements for your oral solids project, you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. Experts in the Pfizer CentreOne global network, Gillian M... -
News New syringe technology could make the 'uninjectable' injectable
Researchers have designed a simple, low-cost device for subcutaneous injection of viscous formulations. -
News BMS adds lead TGF-beta asset to portfolio through acquisition
Forbius's lead investigational asset, AVID200 holds promise as an effective and well-tolerated therapeutic in fibrotic diseases and immuno-oncology. -
News Catalent expands manufacturing support for COVID-19 vaccine AZD1222
The company will prepare the Harmans facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing later this year. -
News CRO Europital opens new UK site in response to urgent demand
The company will target working with small and medium biotechs who require a science-driven, rather than a volume-driven partner. -
News Pharma 2030 and Packaging
An exclusive interview with Mr. Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance -
News Smart packaging solutions to COVID-19 counterfeiting
Developments in smart packaging can add value to the pharmaceutical supply chain and help to tackle the threat of counterfeit products as the race towards producing a COVID-19 vaccine heats up Dr Alex Cole, Senior Strategic Marketing Manager, CPI -
News Cobra Biologics completes production of master cell banks for epilepsy gene therapy drug candidate
This milestone secures future production of CombiGene's CG01 drug candidate to treat drug-resistant focal epilepsy. -
News J&J agrees in principle to supply UK with its COVID-19 vaccine candidate
Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. -
News Sanofi galvanizes strategic product pipeline with Principia Biopharma acquisition
The transaction will enable Sanofi to expand and accelerate development of BTK inhibitors across multiple indications, including MS and other central nervous system diseases. -
News Samsung Biologics adds fourth plant due to growing demand
Plant 4 will add 256 KL capacity to its site, which is scheduled to commence manufacturing activities in the second half of 2022. -
News Moderna inks US deal for 100 million doses of its COVID vaccine
The company is also scaling up its manufacturing capability with its partners — Lonza, Catalent and Rovi — should the vaccine get the green light. -
News Lonza expands microbial capacity and extends partnership with Servier for L-asparaginase API manufacturing
New mid-scale microbial facility will support Servier with API for acute lymphoblastic leukemia therapies. -
News Oxford Biomedica signs 3-year CSA for Parkinson’s disease gene therapy program
The company expects to manufacture the clinical-stage gene therapy product in its commercial-scale GMP manufacturing facilities. -
News Sanofi and GSK in advanced discussions with EU to supply up to 300 million doses of COVID-19 vaccine
Discussions relate to vaccine candidate using Sanofi’s recombinant protein-based technology combined with GSK’s pandemic adjuvant system. -
News Pfizer and BioNTech to supply Japan with 120 million doses of mRNA-based vaccine candidate
The companies are set to manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021. -
News Samsung Biologics invests in expanding aseptic filling capacity at Incheon site
Through this expansion, the CDMO will increase the total lyophilization capacity by 246% of the current capacity. -
News Catalent to create European clinical manufacturing center of excellence in France
The $30 million investment will enable the site to handle large-molecule programs, with additional capacity for small molecule dosage form development. -
News Stevanato Group and Colanar colaborate to study container closure systems
The data generated through the partnership will help biopharma companies to develop robust manufacturing processes and minimize challenges during scale-up and commercialization. -
News Humanigen expands partnership with Catalent to manufacture investigational COVID-19 therapeutic candidate
Data on the first clinical use of lenzilumab in patients with severe COVID-19 pneumonia suggest promising results. -
News ChargePoint Technology and STERIS collaborate to offer fully validated sterile transfer solution
Sterile transfer solutions without compromising operational efficiency. -
News China's first SARS-CoV-2 neutralizing antibody enters clinical trials
Junshi Biosciences cites Lonza’s GS Xceed gene expression system as a critical enabler for the program. -
News Cobra Biologics delivers final plasmids for CombiGene's epilepsy project
Further milestone paves the way for production of novel gene therapy drug candidate designed to treat drug-resistant focal epilepsy. -
News Rentschler Biopharma and Vetter team up to simplify processes
Companies agree that the key to tackling drug development complexity is collaboration. -
News iNova Pharmaceuticals announces the launch of iPitch 2020
Following on from the success of the inaugural iPitch launch in 2019, iNova Pharmaceuticals is delighted to announce the launch of a new round of iPitch challenges for 2020. -
News Ajinomoto introduces fast track platform for drug product manufacturing
AJILITY is designed to speed novel or existing therapeutics from development to manufacturing and into the clinic. -
News PCI Pharma Services completes biotech Center of Excellence
The global outsourcing solutions provider is also set to expand its biotech capabilities in Europe. -
News FDA approves new Dupixent prefilled pen
The prefilled pen supports more convenient self-administration for patients with chronic type 2 inflammatory diseases. -
News Press Release > CordenPharma & Moderna Extend Lipid Supply Agreement for Moderna’s (mRNA-1273) Vaccine Candidate
Luxembourg, 28 May 2020 -- CordenPharma, a full-service Contract Development & Manufacturing Organization (CDMO) for the supply of APIs, Drug Products & Pharmaceutical Packaging, announces the signing of an amendment to their existing manufacturing agr... -
News Emergent to invest $75 million in viral vector manufacturing expansion at Massachusetts site
The investment will add a multi-suite operation to the Canton facility, adding up to 1000L of viral vector capacity and is expected to go online by 2023 -
News BIA Separations introduces PrimaS multi-mode ligand bioprocessing technology
Novel platform initially focussed on high-resolution industrial-scale processing of therapeutic mRNA. -
News Sanofi to build EUR 490 million vaccine production facility in France
The French pharma company will also invest EUR 120 million to create a new research center at Marcy-l'Etoile dedicated to vaccines -
News Catalent to provide AstraZeneca with finishing and packaging for University of Oxford COVID-19 vaccine candidate
Late-stage manufacturing services will be conducted at Catalent’s facility in Anagni, Italy in preparation for large-scale commercial supply of the vaccine -
News WuXi Biologics signs lease for a clinical manufacturing facility in the US
The deal represents the contract manufacturer's third US site. -
News Fujifilm invests $928 million to expand CDMO's biologics production facility in Denmark
Investment will double the site's drug substance manufacturing capacity and will expand its capabilities to include fill/finish, and enhance its current assembly, labeling and packaging services. -
News Oxford Biomedica and VMIC seal UK vaccine manufacturing capacity deal
The collaboration will significantly increase the UK’s capacity to manufacture viral vectors vaccines as part of a national effort in response to COVID-19. -
News Achilles Therapeutics to set up manufacturing operations at the CGT Catapult manufacturing centre
The collaboration with CGT Catapult will enable Achilles to increase its GMP manufacturing capacity to supply clinical trials of its novel T cell therapy products. -
News Emergent BioSolutions signs 5-year manufacturing agreement for J&J’s lead COVID-19 vaccine candidate
The CDMO produce drug substance at large scale for commercial manufacturing with the first 2 years valued at approximately $480 million. -
News FDB to support Tonix in clinical-stage manufacturing for COVID-19 vaccine
Development partners believe orthopoxvirus vaccines have potential for scalability to supply very large markets
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News AGC Biologics acquires AstraZeneca commercial biomanufacturing facility
The Boulder, Colorado, USA facility will increase global capacity and extend manufacturing scale. -
News Emergent bags $628 million "landmark" CDMO deal to produce COVID-19 vaccine candidates
The company will provide CDMO capabilities, capacities, and expertise to support the US government’s Warp Speed Program to pave the way for innovators to advance COVID-19 programs. -
News Stevanato Group to open US Technology Excellence Center in Boston
US TEC will support biopharma drug development throughout the lifecycle, helping them overcome the challenges of the container-closure system. -
News CSL signs up Thermo Fisher in biologics development and manufacturing deal
CDMO will operate new Swiss facility due for completion in 2021 to support production of next-gen haemophilia product -
News AbCellera and Lilly seal multi-year antibody discovery collaboration
AbCellera, will use its antibody drug discovery platform to identify antibodies against up to nine targets. -
News Sifting for gold in the biopharmaceutical talent pool
Evolving biopharma quality demands, the shifting regulatory landscape and the COVID-19 pandemic mean CDMOs will need to get even better at finding talent if they are to strike recruitment gold
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