Amicus Therapeutics, Inc.
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Latest From Amicus Therapeutics, Inc.
CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.
Faced with a lawsuit asserting it had acquired an asset because it was a potential threat, Sanofi bows out of agreement to develop Maze’s GYS1 inhibitor. A test for FTC’s competition theory will be whether MZE001 eventually makes it to the market through other means.
John Crowley will take the reins at BIO in March, about a year and a half after the departure of former CEO Michelle McMurry-Heath was announced.
Ipsen’s Bylvay is one of six medicines that the European Medicines Agency has said should be stripped of their orphan drug designation over the last three years, leading the company to criticize the agency’s approach to “significant benefit” assessments.
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