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Vir Biotechnology plans to launch a phase 2/3 trial this month of VIR-7831, a neutralizing monoclonal antibody for the treatment of COVID-19 patients. Read More
Moderna has secured a $1.5 billion Operation Warp Speed contract to supply 100 million doses of a COVID-19 vaccine candidate to the U.S. government, with an option to supply 400 million more doses if needed. Read More
Fee-paying drug sponsors who submit investigational new drug (IND) applications to the FDA generally get high-quality responses and communications from the agency, according to an independent assessment by Lexington, Mass.-based Eastern Research Group. Read More
Mexico has agreed to host several phase 3 clinical trials of potential COVID-19 vaccines as the pace of research worldwide continues to gain momentum. Read More
Novavax plans to have enough COVID-19 vaccine manufacturing capacity to meet U.S. demand at a minimum, but the Maryland-based vaccine developer is also looking to be able to supply billions of doses next year, the company’s CEO said. Read More
Moderna said that it might not be the first company to make the inventions claimed on patent applications for its COVID-19 vaccine mRNA-1273, and that the company may have to seek patent licenses to market the vaccine. Read More
Russia has approved the world’s first coronavirus vaccine, President Vladimir Putin announced Tuesday, prompting widespread concerns about the vaccine’s safety as it is only entering a late-stage clinical trial this week. Read More
In a final guidance released yesterday, the FDA explains how and when drug sponsors should notify the agency about products that they plan to withdraw from the market or that will not be offered for sale. Read More