BioSpace News Archive

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• 

  Manufacturing

  Pharmas Hope FDA PreCheck Can Help Avoid Facility-Related Drug Rejections

  Executives from Eli Lilly, Merck and other companies foresee the FDA’s new onshoring proposal being anything from a bureaucratic waste of time to a transformative program that will eliminate inspection-related complete response letters.

  October 28, 2025

   · 

  4 min read

   · 

  Nick Paul Taylor
• 

  Opinion

  A Flu Season in Flux Presents Risks, Opportunities for Biopharma

  The coming flu season is the clearest indication yet that biopharma’s long-standing assumptions about predictability, prevention and portfolio structure are no longer guaranteed.

  October 28, 2025

   · 

  7 min read

   · 

  Tom Sebok
• 

  Earnings

  Novartis CEO Says Trump’s Drug Pricing Deals Don’t Address Root Problem

  Vas Narasimhan confirmed that Novartis is having weekly discussions with the Trump administration on drug pricing, but a deal has not yet been reached.

  October 28, 2025

   · 

  3 min read

   · 

  Annalee Armstrong
• 

  Earnings

  BioMarin Abandons Gene Therapy Roctavian, Cuts Revenue Guidance as Voxzogo Faces Competitors

  BioMarin no longer expects to hit its $4 billion revenue target by 2027, citing various market factors such as impending competition for achondroplasia therapy Voxzogo and the divestment of the gene therapy Roctavian.

  October 28, 2025

   · 

  4 min read

   · 

  Tristan Manalac
• 

  Autoimmune disease

  Biogen Seeks To Stand Out in Lupus With New Anti-CD40L Data

  Phase III data for dapirolizumab pegol presented at the 2025 conference of the American College of Rheumatology showed quality-of-life benefits in systemic lupus erythematosus that could see Biogen go head-to-head with GSK and AstraZeneca in a blockbuster space.

  October 28, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Autoimmune disease

  Cabaletta’s CAR T Therapy Spurs Remissions in Small Lupus Trial

  Phase I/II data for rese-cel point to its therapeutic potential in systemic lupus erythematosus and lupus nephritis, as well as other autoimmune conditions.

  October 28, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• Press Releases

  Onward Therapeutics Exercises Exclusive Option and Signs Worldwide License Agreement with Institut du Cancer de Montpellier for Novel Onco-Metabolism Program

  October 28, 2025

   · 

  3 min read
• Press Releases

  Vertex to Participate in the UBS Global Healthcare Conference on November 11

  October 28, 2025

   · 

  1 min read
• Press Releases

  UPDATE - Medidata Extends Collaboration with Sanofi for the Development of New Therapies with an Improved Patient Journey

  October 28, 2025

   · 

  2 min read
• Press Releases

  Agilent Names Adam S. Elinoff as Chief Financial Officer

  October 28, 2025

   · 

  3 min read