Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Biontech, Bridgebio, Sentynl, Cellevolve, Decibel, Junshi, Mediwound, Pfizer, Verismo, Veru, Xpira.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytoreason, Bavarian Nordic, Celsion, Elicio, Immunesensor, Imunon, Menarini, Moat, Novo Nordisk, Octagon.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biogen, Cellresearch, Corium, Neurosense, Novartis, Polypid, Revance, Trevi, Virios.
Virios Therapeutics Inc. said most likely COVID-19 had a hand in the phase IIb failure of IMC-1 (famciclovir + celecoxib), a dual COX-2/COX-1 inhibitor for treating fibromyalgia. The drug failed to hit statistical significance in dampening pain severity when compared to placebo (p=0.302).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Agios, Astrazeneca, Belite, Biontech, Gilead, Kite, Marengo, Merck & Co., Novavax, Pfizer, Sanofi, Stada, Takeda, Xbrane.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biohaven, Bolden, Coherus, GSK, IDT, Thervance and Valneva.
What was once effective is now a non-starter. Newly updated guidelines from the World Health Organization (WHO) caution against using the COVID-19 treatments sotrovimab, from GSK plc and Vir Biotechnology Inc., and Regen-Cov (casirivimab + imdevimab), from Regeneron Pharmaceuticals Inc. Omicron, the group said, has rendered the monoclonal antibodies ineffective.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cage, Cardurion, Enzolytics, Imara, J Ints, Peptistar, Pharvaris, Quince, Sorrento, Syros, Tagcyx, Twist, and Tyme.
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