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The European Medicines Agency (EMA) has released new guidance on the use of good manufacturing practices (GMPs) in the production of biological starting materials for advanced therapy medicinal products (ATMPs). Read More
AstraZeneca and Sanofi said an ongoing phase 3 study has shown that their investigational antibody, nirsevimab, can prevent respiratory syncytial virus (RSV) infections in infants. Read More
Bristol Myers Squibb (BMS) has reported positive findings from two late-stage clinical trials of deucravacitinib, its experimental treatment for moderate-to-severe plaque psoriasis. Read More
As work continues on remedying a host of concerning issues at Emergent BioSolutions’ Bayview, Md., facility, Health Canada has reported that the 1.5 million AstraZeneca (AZ) doses it received from the site were up to par for safety and quality. Read More
The Biden administration has decided to begin sharing its AstraZeneca (AZ) vaccine supply with the rest of the world while the shots go unused in the U.S., as the government also begins delivering supplies of raw materials needed to make the vaccine in COVID-ridden India. Read More
The FDA on Friday amended its Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 vaccine to reflect the risk of rare blood clots and said vaccinations could resume immediately, based on recommendations by a Centers for Disease Control and Prevention (CDC) advisory committee. Read More
Biogen has been gearing up for a U.S. rollout of its controversial, closely-watched Alzheimer’s drug candidate aducanumab despite lingering questions about its chances of FDA approval that will finally be put to rest by the agency’s June 7 target date. Read More