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BioWorld - Monday, December 15, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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Illustration of nasopharyngeal carcinoma

Lepu’s MRG-003 cleared as China’s first EGFR ADC for advanced NPC

Nov. 4, 2025
By Marian (YoonJee) Chu
No Comments
Lepu Biopharma Co. Ltd. said Oct. 30 it won Chinese approval of a novel antibody-drug conjugate (ADC), Meiyouheng (becotatug vedotin injection), making it China’s first epidermal growth factor receptor (EGFR)-directed ADC for advanced nasopharyngeal cancer (NPC).
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Stock chart, red down arrow

Incyte aboard, SMARCA2 shift by Prelude enshrouds Foghorn

Nov. 4, 2025
By Randy Osborne
No Comments
Just as investors were looking ahead to news by year-end on Prelude Therapeutics Inc.’s SMARCA2-targeted degraders, the firm said work in the space will be halted, with efforts shifting toward the mutant selective JAK2V617F JH2 inhibitor program by way of a new deal with Incyte Corp.
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UCB’s ultra-rare disease drug Kygevvi approved by FDA

Nov. 4, 2025
By Lee Landenberger
No Comments
The U.S. FDA has approved UCB SA’s Kygevvi (doxecitine and doxribtimine), the first treatment for the ultra-rare, genetic and life-threatening mitochondrial disease thymidine kinase 2 deficiency. The approval comes as the company reaps a reward of rebuilding and reorganizing that it began little more than a year ago.
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Tug-of-war illustration

Metsera in the middle of Novo, Pfizer bidding war

Nov. 4, 2025
By Karen Carey
No Comments
Pfizer Inc. upped its original $7.3 billion September offer to buy Metsera Inc., but the obesity specialist maintained that a now-improved unsolicited bid by semaglutide developer Novo Nordisk A/S is superior.
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Positive Duchenne data for Santhera, confirmatory miss for Sarepta

Nov. 4, 2025
By Nuala Moran
No Comments
Five-year follow-up data for Santhera Pharmaceuticals AG’s Duchenne muscular dystrophy (DMD) drug, Agamree (vamorolone), confirm that its efficacy in preserving muscle function is comparable to standard-of-care corticosteroids, but that the overall side-effect profile is more benign. There was less positive DMD news from Sarepta Therapeutics Inc.
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Three months later, FDA’s CDER helmless again

Nov. 3, 2025
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A preview of the next edition of BioWorld, Nov. 3, 2025
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Regulatory actions for Nov. 3, 2025

Nov. 3, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Calluna.
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Other news to note for Nov. 3, 2025

Nov. 3, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: 4D Molecular, Ajinomoto, Astellas, Compass, Gilead, Hookipa, Neurokaire, Otsuka.
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In the clinic for Nov. 3, 2025

Nov. 3, 2025
Clinical updates, including data readouts and publications: Astrazeneca, Boost, Celldex, Hightide, Karolinska, Parabilis, Stallergenes Greer, Vesper.
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Financings for Nov. 3, 2025

Nov. 3, 2025
Biopharmas raising money in public or private financings, including: Arcus, Corbus, Liminatus, Nanobiotix.
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