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BioWorld - Friday, February 6, 2026
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Agios planning sNDA on mixed sickle cell data for mitapivat

Nov. 19, 2025
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A preview of the next edition of BioWorld, Nov. 19, 2025
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Gears traveling between drug capsule and head
Neurology/psychiatric

SfN 2025: How ‘latent’ sex differences can trip up drug discovery

Nov. 19, 2025
By Anette Breindl
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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.
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Redemplo packaging

Arrowhead’s plozasiran cleared for FCS; Ionis patent duel awaits

Nov. 18, 2025
By Jennifer Boggs
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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.
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Regulatory actions for Nov. 18, 2025

Nov. 18, 2025
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.
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Other news to note for Nov. 18, 2025

Nov. 18, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Alcyone, Biogen, Halozyme, Merus, Nxera, Relief, Repare, Sensei, Xeno.
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In the clinic for Nov. 18, 2025

Nov. 18, 2025
Clinical updates, including data readouts and publications: Agomab, Beone, Epirium, Jazz, Leo, Nuvalent, Rigel, Siolta.
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Financings for Nov. 18, 2025

Nov. 18, 2025
Biopharmas raising money in public or private financings, including: Algernon, Annexon, Artios, Bambusa, Captain T Cell, Imbria, Inventiva, Mitorx, Nextcure.
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Appointments and advancements for Nov. 18, 2025

Nov. 18, 2025
New hires and promotions in the biopharma industry, including: 4D Molecular Therapeutics, Adaptimmune, Advancell, Bright Minds, Esperion, Fortrea, Mesoblast, Mosaic, Onconano, OSR, Newcelx, Sonoma.
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FDA Approved stamp

Henlius, Organon win US FDA approval of first Perjeta biosimilar

Nov. 18, 2025
By Marian (YoonJee) Chu
No Comments
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).
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Jingsong Wang, CEO, Harbour Biomed

Harbour Biomed launches AI-based antibody development platform

Nov. 18, 2025
By Tamra Sami
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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.
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