Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allogene, Aqualung, Chia Tai-Tianqing, Ensysce, Inventiva, Marinus, Pfizer, Plus, Servier, Sino, South Rampart, Tonix.
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.
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.