FDA Once More Delays Action on Pompe Disease Candidate

The FDA has issued a Deferred Action letter for Amicus Therapeutics’ biologic license application (BLA) for cipaglucosidase alfa, the biologic component of AT-GAA, its investigational dual therapy for muscle-wasting Pompe disease. Source: Drug Industry Daily

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EMA Recommends Minimizing JAK Inhibitor Use for Some Patients

Older people, smokers and those with an increased risk of cardiovascular problems shouldn’t use Janus kinase inhibitors for chronic inflammatory diseases unless there are no other suitable treatment options, according to new recommendations by the European Medicines Agency (EMA). Source: Drug Industry Daily

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FDA Rejects Gilead’s Hepatitis D Therapy Hepcludex

The FDA has declined to green-light Gilead Sciences’ hepatitis delta virus (HDV) drug bulevirtide because of manufacturing and delivery concerns, meaning there will continue to be no approved treatment for the condition in the U.S. Source: Drug Industry Daily

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GSK Gets a Partial Thumbs Up for Anemia Drug, Ends Plans for RA Drug

As the FDA’s decision date on GSK’s new drug application (NDA) for daprodustat — its chronic kidney disease anemia drug candidate — approaches, an FDA advisory panel said Wednesday that it favors the drug for kidney patients on dialysis but not for patients who aren’t. Source: Drug Industry Daily

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