Lilly Needs Updated FDA Authorization To Sell COVID Antibody On Commercial Market
Biden administration will run out of supply of Lilly’s covid antibody bebtelovimab in August, forcing a shift to commercial market due to lack of funds. The transition will require changes to the emergency use authorization and involve a price hike.
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Next-Gen COVID Vaccines Could Be Awesome – If They Ever Get Made
Mucosal and other new vaccines in development should target infection and transmission prevention, as White House’s Ashish Jha calls for them to be ‘better than terrific.’ But with the market transitioning to a flu-like status, incentives for big investments seem limited.
Next-Gen Vaccine Makers Want Up-Front Discussions With US FDA To Expedite Development
Early conversations on clinical trial endpoints were particularly helpful in developing Comirnaty, a Pfizer executive said. Whether sponsors can continue to get such discussions may go a long way in determining whether a new generation of products is developed.
New COVID Therapeutic Development Hitting Regulatory Wall At US FDA
FDA trial design criteria pose challenges for new COVID therapeutic development, frustrating companies and NIH and prompting a tense meeting earlier this summer, according to audio obtained by the Pink Sheet.