Biontech SE agreed to pay up to nearly $1.26 billion in two separate settlements to resolve royalty disputes with the U.S. NIH and the University of Pennsylvania related to the COVID-19 vaccine the company partnered with Pfizer Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Autolus, Neurizon, Novavax, Rapt, Recce, Resq, Zai Lab.
Phase III Scorpio-PEP study results showed Shionogi & Co. Ltd.’s oral antiviral ensitrelvir fumaric acid (Xocova) reduced risk of symptomatic COVID-19 infection in subjects who were exposed to the virus by infected household members.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Cerevance, Foresee, Galderma, Genentech, Gilead, Karolinska, Merck, Mitsubishi Tanabe, Novo Nordisk, Nurix, Regeneron, Regenxbio, Roche.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Astria, GSK, ipsen, Novavax, Theriva, Tonix, Urogen.
Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aurigene, Clearside, Dyne, Entrada, Innocare, Insmed, Panavance, Tevogen, Vanqua, Viatris, Viking.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Ennodc, Expert Systems, Irlab, Theriva, Trawsfynydd.
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