Vertex Diabetes Cell Therapy Back On Track After FDA ‘Hiccup’
Regulator Lifts Clinical Hold
The US firm has received the FDA thumbs-up to continue a trial for its novel cell therapy candidate, VX-880, after what was perceived in some circles as an over-cautious decision by the regulator to pause the study in March.
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Vertex will pay $320m to buy rival ViaCyte, which is developing stem cell therapies for type 1 diabetes, to complement internal work on VX-880, the firm announced.
Chief scientific officer David Altshuler talked to Scrip about the late-stage development plan for a drug that could represent a blockbuster-sized commercial opportunity, after two Phase II studies testing VX-548 met their primary endpoints.