Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, CSL, Evolus, Galderma, Immunitybio, Nexus.
Shionogi & Co. Ltd. won a $375 million project agreement from the Rapid Response Partnership Vehicle to develop its 3CL protease inhibitor, S-892216, as a long-acting injectable for COVID-19 pre-exposure prophylaxis.
Rounding out a year of insider trading charges involving biopharma companies, the U.S. SEC reported Dec. 30 that it had filed a complaint against two top Humanigen Inc. executives, Cameron Durrant, CEO, and Dale Chappell, chief science officer,
for trades based on insider knowledge of FDA actions.
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.
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