PODCAST | Product Development

DMD gene therapies, CBER & NIH: a BioCentury podcast

The landscape for Duchenne muscular dystrophy gene therapies; plus insights from FDA’s Peter Marks and priorities for Monica Bertagnolli 

May 23, 2023 12:24 AM UTC

If FDA approves a gene therapy from Sarepta Therapeutics Inc. (NASDAQ:SRPT) for Duchenne muscular dystrophy, patients will soon face the difficult choice between taking this treatment or waiting for a better option among the “unprecedented” amount of innovation ahead in DMD, as taking both may not be an option, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues assess the landscape for DMD gene therapies ahead of the May 29 PDUFA date for delandistrogene moxeparvovec.

BioCentury Washington Editor Steve Usdin discusses takeaways from his conversation with Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, on The BioCentury Show; three tasks he thinks Monica Bertagnolli should prioritize should she gain Senate confirmation as NIH’s next director; and what the debt ceiling means for the life sciences. And on the heels of Bio€quity Europe, Editor in Chief Simone Fishburn delivers her insights from BioCentury’s European conference.

This week’s podcast is sponsored by Cancer Research Horizons. For information on how to sponsor BioCentury This Week and The BioCentury Show, please contact Sarah Shoaff at

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Sarepta Therapeutics Inc.