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Appointments and advancements for Nov. 11, 2025

Nov. 11, 2025
New hires and promotions in the biopharma industry, including: Acumen, Alpha-9, Celldex, Nurix, Onchilles, Quralis, Simris.
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Biopharma research illustration

Positive readouts validate pipelines, fuel drug developer rally

Nov. 11, 2025
By Amanda Lanier
No Comments
Drug developer stocks strengthened further through September and October, with the BioWorld Drug Developers Index (BDDI) rising from a 7.69% gain at the end of August, to 24.91% through the third quarter and 28.96% at October’s close. The BDDI outperformed both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which finished October up 24.49% and 11.8%, respectively.
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Liver anatomy with virus

Bluejay way: Positive phase II data for treating hepatitis D

Nov. 11, 2025
By Lee Landenberger
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Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus, a condition with no approved treatment in the U.S.
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Pill with Euro currency symbol
FT Global Pharma and Biotech Summit

Trump’s MFN price deals a wake-up call for governments in Europe

Nov. 11, 2025
By Nuala Moran
No Comments
The industry has been complaining about the drug pricing and reimbursement policies of European governments for years, but only now with the Trump administration’s moves to enforce most favored nation (MFN) pricing and reduce the U.S./EU price gap are governments facing up to the reality that they will have to pay more for new drugs.
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Art concept for bladder

Up the bladder ladder, Engene tweak means phase II bell rung

Nov. 11, 2025
By Randy Osborne
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Engene Holdings Inc.’s protocol amendment to its phase II trial with detalimogene voraplasmid in bladder cancer worked out in a big way, and shares of the firm closed Nov. 11 at $8.82, up $2.81, or 47%. Engene rolled out additional preliminary data from the pivotal cohort of the ongoing Legend study testing the nonviral gene therapy in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease.
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Engene soars on phase II data with detalimogene in bladder cancer

Nov. 11, 2025
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A preview of the next edition of BioWorld, Nov. 11, 2025
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Lab mouse and test tubes
Drug design, drug delivery & technologies

UK launches strategy to replace animals in research as scientists voice concern

Nov. 11, 2025
By Nuala Moran
No Comments
The U.K. government has published a road map for phasing out animal testing in life sciences research and announced £75 million (US$98.6 million) for work to develop nonanimal models, leaving scientists concerned because they say, in many cases, there can never be meaningful alternatives to using live animals.
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Regulatory actions for Nov. 10, 2025

Nov. 10, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Johnson & Johnson, Rhythm, Sanofi.
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Other news to note for Nov. 10, 2025

Nov. 10, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Arena, Evinova, Harbour, Fresenius Kabi, Intellia.
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In the clinic for Nov. 10, 2025

Nov. 10, 2025
Clinical updates, including data readouts and publications: A2, Alebund, Aulos, Bayer, Bioatla, Eledon, Gilead, Indapta, Nurix, Regeneron, Sanofi, Synthekine.
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