Hoping To Smooth Relations With FDA, Sarepta Moves On From CEO Garabedian

Seeing Garabedian’s relationship with FDA as strained, Sarepta promotes Chief Medical Officer to interim CEO post in hopes of keeping eteplirsen on track for a mid-year NDA filing.

The ouster of Sarepta Therapeutics Inc. CEO Chris Garabedian and his temporary replacement by Chief Medical Officer Edward Kaye is intended to smooth the development and regulatory path forward for the company’s Duchenne muscular dystrophy treatment eteplirsen.

Kaye and interim chairman John Hodgman attempted to be diplomatic in their comments about the changeover at the Cambridge, Mass.-based...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from United States

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By 

The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

More from North America