In another sign that fortunes may be changing for those developing Duchenne muscular dystrophy (DMD) treatments, Prosensa Holding BV announced that it will be pursuing an NDA filing with FDA before year’s end. The news is a positive turnaround for Prosensa after the drug, drisapersen, failed in a Phase III clinical trial and its big pharma partner, GlaxoSmithKline PLC, walked away.
Prosensa Finds Path Forward For Drisapersen In DMD Drug Revival
The Dutch company received positive news for its development programs in the U.S.; an encouraging sign for a disease space that has been flailing in recent months due to unclear clinical endpoints.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
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The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.
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The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.