1. Scrip
  2. >>Business
  3. >>Strategy

Peter Marks’ Departure From FDA Rattles Biopharma Industry

XBI Reaches A New 2025 Low

 
• By Mandy Jackson

Stock prices plummeted, particularly for vaccine makers and cell and gene therapy developers, after the US FDA’s top biologics overseer resigned over vaccine misinformation concerns.

FDA review of vaccines and cell and gene therapies could be held up under new CBER leadership (Shutterstock)
Key Takeaways
  • The resignation of CBER director Peter Marks hit biopharma stocks hard as the FDA leadership shakeup increased regulatory uncertainty, particularly for vaccines and cell and gene therapies.

News that US Food and Drug Administration Center for Biologics Evaluation and Research (CBER) director Peter Marks submitted his resignation,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Strategy

Tonix Ready To Revive Fibromyalgia Market With Tonyma

 
• By Joseph Haas

The first new drug for fibromyalgia since 2009, Tonyma is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

Deal Watch: Lilly Teams With GPCR-Focused Superluminal In Cardiometabolic Disease

 
• By Joseph Haas

Plus deals involving Basilea/Venatorx, CorMedix/Melinta, SERB/Y-mAbs, XOMA/Lava, XOMA/Hillevax, MaxCyte/Adicet/Anocca and Bausch Health/DURECT.

Asia Deal Watch: Lupin Picks Sandoz To Market Lucentis Biosimilar In Parts Of EU And Asia

 
• By Joseph Haas, Sushmita Panda, Xu Hu, Vibha Ravi, and Manas Mishra

Also deals involving Xspray/Handa, Fosun/Expedition, Kaken/Astria, Orchid/Allecra, Sanofi/Visirna, KKR/Healthcare Royalty Partners, Viridian/Kissei, Sandoz/Evotec, Dx&Vx, Dr. Falk/Allianthera, Madrigal/CSPC and Lilly/LTZ.

More from Scrip

Executives On The Move: Instylla And Geron Get New CEOs

Recent moves in the industry include changes at the top at Meitheal Pharmaceuticals, Ardelyx and AIRNA, plus five companies get new CMOs.

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

Sarepta Sells Arrowhead Shares To Raise Cash, Pay Arrowhead

 
• By Mandy Jackson

Sarepta is in a cash crunch with sales of Elevidys slumping due to safety concerns and with financial commitments coming due, including debt repayments and milestone fees for its partner Arrowhead.