Eli Lilly and Co received a subpoena late last week from the US Department of Justice (DOJ), requesting certain documents, as part of a probe into its manufacturing site in Branchburg, New Jersey.
Samsung Biologics will add mRNA vaccine drug substance production capability to its facility in South Korea, aiming to provide end-to-end mRNA vaccine manufacturing services.
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has given the green light for the Pfizer/BioNTech COVID-19 vaccine to be administered to adolescents aged 12-15 years old.
Engine Biosciences, a Singapore- and Silicon Valley-based company with an artificial intelligence-enabled technology platform that is designed to discover new biology targets and disease-causing links amongst known targets, has generated US$43m in a Series...
The World Health Organization (WHO) and the Swiss Confederation have launched the first WHO BioHub Facility to enhance the rapid sharing of viruses and other pathogens between laboratories and partners globally.
Pfizer has enrolled the first subjects in a study exploring the co-administration of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 vaccine.
Seasonal flu vaccines typically work 40-60% of the time, according to the US Centers for Disease Control and Prevention (CDC). An experimental recombinant protein nanoparticle vaccine that stimulates a strong immune response is hoping to address that...
Univercells Technologies’ scale-x carbo bioreactor is to be used at the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin, Ireland.
Biogen and Ginkgo Bioworks say their collaboration and license agreement will develop a next-generation AAV production platform, aiming to ‘redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors’.
Vaccine effectiveness against symptomatic disease from the B.1.617.2 (‘India’) variant is similar to that found against the B.1.1.7 ('UK') variant, according to a new study.
Canadian biotechnology company, Medicago, announced positive interim Phase 2 results this week for its plant-derived COVID-19 vaccine, which has been tested in combination with GSK’s pandemic adjuvant.
Gamma Biosciences has taken a controlling investment in Mirus Bio, an innovator and developer of biomimetic, cell-adaptive lipid-polymer nanocomplexes (LPNCs) for nucleic acid delivery based in Wisconsin in the US.
The European Commission today announced that it has reserved an additional 1.8 billion doses of the coronavirus vaccine developed by Pfizer-BioNTech, on behalf of all 27 EU countries, from the end of 2021 to 2023.
Thermo Fisher Scientific Inc and the University of California, San Francisco (UCSF) have formed a alliance to accelerate the development and manufacturing of cell-based therapies.
Becton, Dickinson and Company (BD) is to build a new plant in Zaragoza, Spain, with an investment of €165m (US$200m). The site will produce glass pre-filled syringes and plastic components.
Protalix BioTherapeutics is planning to propose a virtual or record review inspection to clear the barrier to approval of its Chiesi Farmaceutici-partnered Fabry disease treatment.
Data management in antibody drug conjugate (ADC) manufacturing is challenging says ADC/Labs, which is trying to help scientists in the field get around such obstacles.
Novartis subsidiary, Sandoz, says the US Supreme Court has denied its petition to review the Federal Circuit’s decision last summer in relation to Erelzi, its biosimilar of the Amgen reference medicine, Enbrel (etanercept), which is used to treat autoimmune...
Excipient producer, DFE Pharma, is expanding its reach, capitalizing on increasing growth in the biologics sector, and launching a new sucrose stabilizer.
Charles River Laboratories International Inc is to acquire US based Vigene Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) providing viral vector-based gene delivery solutions for research and clinical...
Synlogic is set to increase its manufacturing capacity by more than 50% in preparation for the start of late-stage development of its two lead drug candidates.
Sanofi and GSK announced today that their COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase 2 trial.
Many turn to Boston and North Carolina’s Research Triangle to set up life science companies, but Chicago is now also fast becoming a draw in this respect. The city is emerging as a life science and biopharma hub and seems poised for even further growth,...
The antibody response in people aged 80+ is three and a half times greater when the second dose of the COVID-19 vaccine is administered after 12 weeks, compared to the response when the second dose is given after three weeks, according to a UK study....
The Medicines and Healthcare products Regulatory Agency (MHRA) has published final guidance on how the UK will license biosimilar products now it is outside of the European Union.
Novasep has announced a further expansion of its Highly Potent Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities at its Le Mans, France site, saying the move strengthens its position as a leading CDMO for the production of innovative...
When it comes to continuous manufacturing, software challenges are greater than the hardware challenges faced in setting up a new manufacturing line, because at this time, due to a lack of standardization, debugging and validation can be significant components...
Moderna has agreed to provide 15m doses of its updated variant COVID-19 vaccine to Australia, providing a boost to its efforts to generate ongoing revenues from its coronavirus work.
Connectivity of unit operations is a key enabler for continuous manufacturing to deliver benefits of not only improved mass throughput, but ultimately reduced COGS and increased facility utilization, says Merck.
The need to vaccinate billions of people against COVID-19 as quickly as possible has caused demand for bioprocessing equipment to soar in recent quarters. Now, amid questions about whether demand from the pandemic is peaking, the industry is preparing...
Continuous bioprocessing facilities can be more cost-effective than stainless steel batch plants when total out-of-pocket costs across development and commercial activities are factored in, according to a study.
Charles River says the combination of Distributed Bio’s platform, which the CRO recently acquired, with its own downstream characterization capabilities, enables identification of the best lead candidate in CAR T cell therapies – balancing efficacy and...
RoslinCT is set to collaborate with the Scottish Universities Life Sciences Alliance (SULSA) and additional academic institutions to deliver high impact advanced therapy and vaccine manufacturing GMP training.
Eli Lilly and Company and MiNA Therapeutics Ltd have announced a global research collaboration to develop novel drug candidates using MiNA’s proprietary small activating RNA (saRNA) technology platform.
The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine: now including adolescents aged 12-15 years old.
US contract research organization, PPD Inc, is expanding its Athlone, Ireland, GMP laboratory, significantly increasing the size of its current facility and adding cell and gene therapy (CGT) testing to the operation’s portfolio of services.
Flagship Pioneering has unveiled Laronde: a platform company developing Endless RNA. Endless RNA is a novel, engineered form of RNA that can be programmed to express therapeutic proteins inside the body: ‘a groundbreaking therapeutic platform capable...
BioNTech plans to expand its global footprint with a regional headquarters for South East Asia in Singapore; as well as a fully integrated mRNA manufacturing facility.
![WHO Director-General, Tedros Adhanom Ghebreyesus and Swiss Federal Councillor, Alain Berset, signed an agreement in relation to the BioHub on the edges of the World Health Assembly yesterday [May 24] © WHO/Christopher Black](/var/wrbm_gb_food_pharma/storage/images/_aliases/news_teaser_medium/publications/pharmaceutical-science/biopharma-reporter.com/article/2021/05/26/new-switzerland-hub-for-pathogen-storage-sharing-and-analysis/12512537-4-eng-GB/New-Switzerland-hub-for-pathogen-storage-sharing-and-analysis.jpg)
