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FDA’s Unger On Exondys Approval As Precedent: 'We Hope Not'

 
• By Ramsey Baghdadi

The review manager most opposed to the eteplirsen approval offered his views of the process that led to the final decision and the 'circus' atmosphere of the advisory committee.

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Ellis Unger, Director of FDA’s Office of Drug Evaluation I, is still not happy about how the accelerated approval of Sarepta Therapeutics Inc.’s Exondys 51 (eteplirsen) played out and he’s not pulling any punches about his feelings on the review.

A remarkable panel at the New York Academy of Sciences on June 22 featured brutally honest yet measured commentary on...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

EU Tests Unified Pathway For Combined Drug/IVD Studies

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

More from R&D

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

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.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.