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Gilead Sciences has said its antiviral Veklury (remdesivir) reduced hospitalization and death rates for COVID-19 patients, based on new results from three real-world studies. Read More
The court said 80 million doses must be delivered by Sept. 27, and that the company will face a fine for each dose not delivered by that deadline. Read More
The Biden administration yesterday launched a $3 billion program to develop antiviral medicines for treating COVID-19 and confronting future pandemics. Read More
The FDA has approved a third batch of Johnson & Johnson (J&J) COVID-19 vaccine drug substance for release from the embattled Emergent plant in Baltimore, Maryland — but still hasn’t authorized the Bayview facility to resume production. Read More
The U.S. and EU reached an agreement to reduce export restrictions for COVID-19 vaccines and therapeutics at a Tuesday summit meeting in Brussels. Read More
AstraZeneca’s monoclonal antibody cocktail, AZD7442, failed to prevent symptomatic COVID-19 infection in a late-stage study of individuals recently exposed to the SARS-CoV-2 virus. Read More
The FDA has declined to authorize Bharat Biotech’s COVID-19 vaccine, Covaxin, for emergency use, prompting the Indian drugmaker’s U.S. partner, Ocugen, to instead seek a full approval of the shot through a Biologics License Application (BLA). Read More
Novavax said it plans to file for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in the third quarter, supported by the strong efficacy data from its late-stage trial in which the recombinant DNA-based vaccine proved 100 percent effective in preventing moderate and severe disease, and more than 90 percent effective at preventing symptomatic infections. Read More
Emergent BioSolutions’ troubled Bayview, Md., plant, a manufacturing site for Johnson & Johnson’s COVID-19 vaccine, repeatedly failed to seal off a preparation area for vaccine ingredients and allowed production garbage to be carried through the area, leading to contamination, explains Peter Marks, director of FDA’s Center for Biologics Evaluation and Research in a memorandum about the plant’s operations. Read More