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BioWorld - Wednesday, December 31, 2025
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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Regulatory actions for Nov. 20, 2025

Nov. 20, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Abbvie, Arrowhead, Insmed, Merck, Oncolytics, Regeneron, Roche.
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Other news to note for Nov. 20, 2025

Nov. 20, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Aptose, GSK, Hanmi, Kazia, Nona, Pfizer, Scynexis.
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In the clinic for Nov. 20, 2025

Nov. 20, 2025
Clinical updates, including data readouts and publications: Agio, Eledon, Eyepoint, Lynk, Merck, Protara, Purdue, Roche, Vanda.
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Financings for Nov. 20, 2025

Nov. 20, 2025
Biopharmas raising money in public or private financings, including: AI Proteins, Fibrobiologics, Genmab, HCW, Hemostemix, Lifordi, Mendus, Nervgen, Nuvalent, Olema, Seragene, Skeletalis.
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Appointments and advancements for Nov. 20, 2025

Nov. 20, 2025
New hires and promotions in the biopharma industry, including: Ability, Autoimmunity, Avenzo, Elicio, Hyloris, Minerva, Neurona, Nuvig, Resverlogix.
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Gavel and scales

Fed Circuit lets Sandoz off $39M hook

Nov. 20, 2025
By Mari Serebrov
No Comments
Sandoz Inc. came out the big winner Nov. 18 when the U.S. Court of Appeals for the Federal Circuit wiped out $39 million in infringement damages a jury had awarded to Allergan plc. Sandoz overcame “the doubly high burden of persuading us to overturn a jury verdict of no invalidity,” the appellate court said in its precedential opinion.
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Green molecules

UK Biobank delivers largest metabolomics dataset of 500K profiles

Nov. 20, 2025
By Nuala Moran
No Comments
It’s the biological resource that keeps on giving, and now UK Biobank has released the final tranche of data on the levels of 249 metabolites in the blood of its half a million participants.
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Hands holding gears

GSK-Flagship deal validates Profound, Quotient platforms

Nov. 20, 2025
By Karen Carey
No Comments
Two Flagship Pioneering Inc. biopharma companies founded in the last five years and focused on proteomic and genomic technologies entered agreements to help discover new therapeutics for respiratory and liver diseases under a framework collaboration with GSK plc. Under that agreement, Profound Therapeutics Inc. and Quotient Therapeutics Inc. would use their platform technologies to discover novel proteins and targets for developing drugs to treat chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis, with Quotient taking on a third indication with metabolic dysfunction-associated steatohepatitis.
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Lungs

Bayer’s HER2-mutated lung cancer treatment gets FDA nod

Nov. 20, 2025
By Lee Landenberger
No Comments
A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer.
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Bayer’s HER2-mutated lung cancer treatment gets FDA nod

Nov. 20, 2025
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A preview of the next edition of BioWorld, Nov. 20, 2025
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