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Novavax has announced that it has completed enrolling 30,000 participants in its late-stage U.S./Mexico pivotal trial of its COVID-19 vaccine, bringing its recombinant protein-based vaccine hopeful one step closer to potential FDA authorization. Read More
The FDA has published draft guidance letting COVID-19 vaccine developers that modify authorized vaccines against new viral variants know what they need to present to the agency for amending Emergency Use Authorizations (EUAs), noting that it doesn’t expect large-scale trials will be needed for the altered versions. Read More
Alembic Pharmaceuticals, a sterile drug manufacturer in Gujarat, India, drew a Form 483 inspection report from the FDA with five observations following a Jan. 28 – Feb. 6 inspection. Read More
In the latest in a series of recent moves that greatly expand its presence in cell and gene therapies, Charles River Laboratories is acquiring Cognate BioServices, a Baltimore, Md.-based cell and gene therapy contract development and manufacturing firm for $875 million. Read More
A federal judge has dismissed a lawsuit filed by hospital associations against HHS aimed at compelling it to take action against drugmakers who decline to offer 340B drug discounts to contract pharmacies. Read More
Johnson & Johnson (J&J) has filed with the World Health Organization (WHO) for an Emergency Use Listing (EUL) for its COVID-19 vaccine — a listing that would clear the way for the vaccine to be distributed through the WHO’s COVAX vaccine-sharing program. Read More
Pfizer and BioNTech have filed for a revised Emergency Use Authorization (EUA) from the FDA to allow their COVID-19 vaccine to be stored at easier-to-accommodate freezer temperatures. Read More
An analysis by researchers at the University of Oxford has found that the AstraZeneca (AZ)/Oxford coronavirus vaccine appears more effective when its two doses are administered three months apart, results in line with those unveiled by AZ earlier this month. Read More
A study conducted in Israel, which has already vaccinated a large percentage of its population, has found that a single dose of Pfizer/BioNTech’s COVID-19 vaccine is highly effective at reducing infection, lending more support to the strategy of delaying second doses to increase initial vaccinations. Read More