STAT+: Vertex stem cell therapy spurs insulin independence
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Good morning! Today, we get deeper into the ousting of Nicole Verdun at the FDA, see promise from Vertex\u2019s cell therapy for diabetes, and unpack the story of developing the newly approved Gilead PrEP drug lenacapivir.<\/p>\n
The sudden removal of Nicole Verdun, the FDA\u2019s top cell and gene therapy regulator, followed a dispute with her boss, Vinay Prasad, over holding a public advisory committee meeting on a cell therapy for Duchenne muscular dystrophy made by Capricor Therapeutics, STAT reports<\/a>. Prasad unilaterally canceled the meeting, escalating internal tensions and leading to Verdun and her deputy being placed on administrative leave and escorted out of FDA headquarters \u2014 an unusually harsh move that stunned agency staff and industry alike.<\/p>\n Though Verdun faced management complaints, she was widely respected for balancing urgency with rigor. The shakeup comes amid mounting concern over inconsistent regulatory standards for high-stakes gene therapies. Notably, multiple agency employees have told STAT that Prasad is uninterested in the administrative aspects of running CBER \u2014 meaning that more expert managers in the department are critical.<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n