BioSpace News Archive

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  Immunology and inflammation

  Rush of Targeted Myasthenia Gravis Therapies Hit Once Sparse Market

  After decades without much movement, a handful of new treatments for this rare autoimmune disease are now approved, and several companies, including argenx and Regeneron, have recently released promising late-stage trial results.

  September 15, 2025

   · 

  6 min read

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  Amanda Heidt
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  Obesity

  EASD 2025: Orforglipron in Focus, the Case for Cardiovascular Benefits, More

  While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this week, experts told BioSpace the conference will also provide important insights into the therapeutic benefits of incretin therapies beyond weight loss.

  September 15, 2025

   · 

  6 min read

   · 

  Tristan Manalac
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  Europe

  AstraZeneca Suspends $270M UK Commitment Months After Scrapping Vaccine Facility

  AstraZeneca in January also stopped its $610 million plans to construct a vaccine R&D and manufacturing site in the U.K.

  September 15, 2025

   · 

  2 min read

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  Tristan Manalac
• 

  Collaboration

  Novartis Sticks With Monte Rosa in Second Molecular Glue Deal Worth up to $5.7B

  Novartis and Monte Rosa first partnered in October 2024 for a molecular glue asset for immune-mediated and autoimmune diseases. This time, the pharma is putting $120 million down upfront for more of the biotech’s AI-discovered degraders.

  September 15, 2025

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  2 min read

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  Tristan Manalac
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  Adcomms

  FDA Flip-Flops on Scrapping Adcomms

  CDER Director George Tidmarsh said on two separate events last week that he thought advisory committee meetings for specific drug applications were redundant, but then denied having said the agency would abandon them.

  September 15, 2025

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  2 min read

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  Tristan Manalac
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  FDA

  FDA Action Alert: Merck, Sanofi, Biogen and More

  On the FDA’s docket for the back half of September is Merck’s proposed subcutaneous formulation of its blockbuster cancer drug Keytruda.

  September 15, 2025

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  6 min read

   · 

  Tristan Manalac
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  Sponsored

  Rosnilimab Shows Promise as a Potential Next-Generation RA Therapy

  A depleter of pathogenic T cells, rosnilimab’s novel MOA generated a differentiated efficacy, tolerability and safety profile in recent Phase 2b study

  September 15, 2025

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  7 min read
• Press Releases

  Monopar to Present New Long-Term Neurological Efficacy and Safety Data for ALXN1840 in Wilson Disease at the 150th American Neurological Association Annual Meeting

  September 15, 2025

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  5 min read
• Press Releases

  Akeso Announces First Patient Dose in Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma

  September 15, 2025

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  6 min read
• Press Releases

  Lion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B Following Earlier Fast Track and Orphan Drug Designations

  September 15, 2025

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  3 min read