Given the safety and efficacy data presented June 7 for Novavax Inc.’s COVID-19 vaccine, NVX-CoV2373, it came as no surprise when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee voted 21-0, with one abstention, to support an emergency use authorization for the vaccine, which is already approved and being used in many other countries, including the EU and Canada.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Affibody, Alx, Aurinia, Biogen, Biothera, Incannex, Inmagene, Intercept, Merck, Nicox, Novo Nordisk, Olix, Sorrento, Tranquis.
Shares of Novavax Inc. dropped 19% after briefing documents released ahead of the U.S. FDA’s June 7 advisory committee raised concerns about risks of myocarditis associated with COVID-19 vaccine NVX-CoV2373, though reviewers also noted the vaccine could offer protection against the omicron variant. The stock (NASDAQ:NVAX) closed June 3 at $44.76, down $11.21.
Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Achieve, Alpine, Aruna, Asher, Astellas, Cocrystal, Coda, GSK, ICER, Merck, Neuexcell, Orphazyme, Scineuro, Theolytics and Virios.
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