At the 2025 annual meeting of the Society for Neuroscience in San Diego this week, Catherine Woolley’s plenary lecture was an unusual combination of debunking and affirming the importance of sex differences in the brain.
Arrowhead Pharmaceuticals Inc. won U.S. FDA approval of plozasiran in familial chylomicronemia syndrome (FCS), the second drug to gain clearance for use in the rare genetic disease following the late 2024 nod for Ionis Pharmaceuticals Inc.’s Tryngolza (olezarsen), setting up a battle in the marketplace even as the firms wage a patent dispute regarding the two RNA-based therapies.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Arcutis, Ascelia, Biogen, Bioinvent, Henlius, Incyte, Medicus, Obi, Organon, Sarepta, Silo, T-knife.
Biopharma happenings, including deals and partnerships, and other news in brief: Alcyone, Biogen, Halozyme, Merus, Nxera, Relief, Repare, Sensei, Xeno.
Biopharmas raising money in public or private financings, including: Algernon, Annexon, Artios, Bambusa, Captain T Cell, Imbria, Inventiva, Mitorx, Nextcure.
Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.
Growth factor specialist Agomab Therapeutics NV is now preparing to move into phase IIb development after delivering positive phase IIa results for its lead program, ontunisertib, an orally available treatment for fibrostenosing Crohn’s disease.
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