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Former FDA Commissioner Mark McClellan says it’s possible that a COVID-19 vaccine will be available for some portions of the population before year’s end but that it was never realistic to expect one before the Nov. 3 presidential election. Read More
The Serum Institute of India (SII) has announced it will produce up to 100 million additional COVID-19 vaccine doses through its collaboration with the Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance to supply India and lower income nations. Read More
Regeneron Pharmaceuticals yesterday unveiled early data on its COVID-19 antibody cocktail in which the drug appeared to provide a benefit for nonhospitalized COVID-19 patients. Read More
There is no sign of a slowdown in letters to the FDA seeking assurances that the agency will not bend to political pressure to approve a COVID-19 vaccine ahead of the Nov. 3 presidential election. Read More
Philip Krause, deputy director of the FDA’s Office of Vaccines Research and Review, said this week that the fate of the agency’s guidance on its expectations for COVID-19 vaccine Emergency Use Authorization (EUA) remains uncertain as it goes through the White House’s review. Read More
GlaxoSmithKline (GSK) has launched a phase 2 trial in the UK of its investigational rheumatoid arthritis treatment otilimab for hospitalized COVID-19 patients. Read More
The FDA has placed a partial clinical hold on Inovio Pharmaceuticals’ planned phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, calling for more information. Read More
“The CE mark allows us to support many more clinical labs and organizations globally, including those performing COVID-19 testing during the current pandemic,” the company said. Read More