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Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease. Analysts say prospects of the therapy, Elevidys, rest on FDA willingness to exercise flexibility it has already shown to rare disease drugmakers, including Sarepta.
United Kingdom Joseph Schwartz Tim Lugo Doug Ingram William Blair Reata Pharmaceuticals

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48 Senators Urge Biden Administration To Mandate Coverage of OTC Contraceptives

Several senators wrote a letter to the Biden Administration asking for action that ensures coverage of over-the-counter birth control without the need for a prescription. The letter was led by Senators Patty Murray (D-Washington), Tammy Baldwin (D-Wisconsin), Bernie Sanders (I-Vermont) and Ron Wyden (D-Oregon).
Tammy Baldwind Wisconsin Patty Murrayd Washington Bernie Sandersi Vermont Ron Wydend Oregon Dana Singiser Access Initiative

MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Jeff Smith, CEO of Bamboo Health

For the October episode, we discuss some recent executive hires and departures occurring in the healthcare sector, as well as layoffs affecting the industry. We also hear from Jeff Smith, who became the new CEO of Bamboo Health this month.
Jeff Smith Intermountain Health Novant Health Bamboo Health Medcity Moves Podcast Sana Biotechnology

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