Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alligator, Alnylam, Antengene, Aptevo, Artiva, Astrazeneca, Beigene, Bluebird, Bristol Myers Squibb, Cyxone, First Wave, Genentech, Heron, Leo, Medexus, Psyence, Roche, Seagen, Xortx.
President Joseph Biden’s recent statement that the COVID-19 pandemic is over may or may not reflect popular fatigue with the associated public health emergency (PHE), but the statement struck a different tone in some quarters on Capitol Hill. Sen. Richard Burr (R-N.C.) was one of several who argued that the need for the PHE had thus necessarily run its course, with Burr specifically calling into question the need for additional funding for COVID-related federal health efforts.
The U.S. response to the emergence of the COVID-19 pandemic may by now be the stuff of public health policy lore, with both the FDA and the CDC contributing to the chaos in the first months of the pandemic. The Office of Inspector General has issued an analysis of the situation, and while OIG revisited some of the known miscues, the report also made the case that a national strategy for pandemic response will be needed if federal government efforts in the future are to be less a hazard to the lives of American citizens than those seen in the first half of 2020.
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.
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