BioSpace News Archive

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  Events

  Register: FDA in 2025: Navigating an Uncertain Regulatory Future

  The FDA is undergoing a major transformation in its drug approval processes, regulatory oversight and transparency initiatives. Join us for a live webinar exploring the implications of these reforms and what they mean for innovation, compliance and strategy in the biopharma industry.

  October 6, 2025
• Events Feed

  October 6, 2025
• Melanie Whittington

  Melanie Whittington is a managing director and head of the Center for Pharmacoeconomics at MEDACorp, where she leads efforts to demonstrate the societal impacts of healthcare treatments in the U.S.
• 

  Jason Housley

  Jason Housley is the senior director of customer strategy and success at eClinical Solutions.
• 

  Opinion

  Gene Therapy’s Future Hinges on the Economics of Safety

  Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures.

  October 6, 2025

   · 

  7 min read

   · 

  Ronald A. Li
• 

  Multiple sclerosis

  Beyond BTK Inhibitors: Next Gen MS Treatments Could Transcend Symptom Management

  While Bruton’s tyrosine kinase inhibitors are often hailed as the next big breakthrough in multiple sclerosis, Immunic Therapeutics and others are leveraging neuroprotective targets and remyelination to keep the disease at bay.

  October 6, 2025

   · 

  5 min read

   · 

  Ben Hargreaves
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  Cell and Gene Therapy

  Meeting on the Mesa Arrives Amid Mixed Signals for Cell and Gene Therapy

  As industry leaders gather at the annual event in Phoenix, the cell and gene therapy space remains in a state of flux, with M&A activity and regulatory support signaling momentum while commercialization challenges continue to hinder broader investor interest.

  October 6, 2025

   · 

  5 min read

   · 

  Ben Hargreaves
• 

  Mergers & acquisitions

  Chiesi, Arbor Weave $2.1B Rare Disease Pact

  The centerpiece of the collaboration is the gene editor ABO-101, being developed for primary hyperoxaluria type 1, a rare disease that leads to severe kidney stones.

  October 6, 2025

   · 

  1 min read

   · 

  Tristan Manalac
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  Gene therapy

  Rocket Aborts FDA Filing for Rare Blood Disease Gene Therapy

  Rocket Pharmaceuticals’ strategic realignment initiative in July pulled funding from fanca-cel, which the biotech was developing for Fanconi anemia.

  October 6, 2025

   · 

  2 min read

   · 

  Tristan Manalac
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  Manufacturing

  FDA Continues US Manufacturing Drive With Domestic Generics Pilot

  This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.

  October 6, 2025

   · 

  2 min read

   · 

  Tristan Manalac