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In a move to show it’s a good corporate citizen during the pandemic, Moderna has vowed not to wield its COVID-19 related patents against other coronavirus vaccine manufacturers as the crisis continues. Read More
Regeneron Pharmaceuticals submitted a request for Emergency Use Authorization (EUA) for its COVID-19 antibody treatment Thursday, just one day after Eli Lilly filed for authorization of its own monoclonal antibody. Read More
The expert panels are weighing the drug’s risks and benefits, including potential public health impacts and whether the evidence supports abuse-deterrent labeling. Read More
The editors of the New England Journal of Medicine have broken with the medical journal’s long tradition of avoiding political issues and published a scathing criticism of the government’s management of the COVID-19 crisis, claiming that the FDA has been “shamefully politicized.” Read More
The biosimilars market has had a plodding start in the U.S., but the products are finally picking up momentum, IQVIA reported, citing three examples of new products with strong potential. Read More
Dozens of medical experts from across the nation have written a letter to FDA Commissioner Stephen Hahn, Center for Biologics Evaluation and Research (CBER) Director Peter Marks and the FDA’s vaccine advisory committee calling for stronger requirements for monitoring participants in COVID-19 vaccine trials. Read More
Eli Lilly has submitted a request for an Emergency Use Authorization (EUA) for its monoclonal antibody LY-CoV555, following new positive trial data for its antibody combo in treating COVID-19. Read More
In the U.S., the federal government said it no longer has to control the distribution process because there is a sufficient supply to treat COVID-19 patients. Read More
The European Medicines Agency (EMA) began its second expedited review of a COVID-19 vaccine candidate, starting its evaluation of data for Pfizer/BioNTech’s vaccine hopeful BNT162b2 on Tuesday. Read More
Rick Bright, the former director of NIH’s Biomedical Advanced Research and Development Authority (BARDA), has resigned from the institute, alleging that its leadership failed to assign him meaningful work and ignored his recommendations because of politics. Read More
Despite the White House reportedly blocking the FDA’s tighter requirements for COVID-19 vaccine Emergency Use Authorizations (EUAs), the agency has opted to release them. Read More