BioCentury This Week
BioCentury's streaming commentary on biotech industry trends, plus interviews with KOLs.
For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.
BioCentury This Week
Ep. 202 - A DMD Decision & Endpoint Innovation
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The controversy around Sarepta continues as the company’s executives were confident last week that the data from the Phase III EMBARK trial of Duchenne muscular dystrophy gene therapy Elevidys were enough to warrant full approval despite missing the study’s primary endpoint. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the pitfalls facing FDA as the agency considers whether to apply regulatory flexibility in its decision-making and the impact its decision could have for patients and future therapies that are submitted to the agency with less than clear-cut positive data. The editors also discuss innovations around new endpoints and technologies for clinical trials and the tepid reception for the latest biotech IPO, the debut by Lexeo.
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