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Dublin, Ireland-based Jazz Pharmaceuticals has scooped up FDA approval for its hepatic veno-occlusive disease treatment Defitelio, the first approved therapy to treat the rare and life-threatening liver condition. Read More
Aveo Pharmaceuticals will pay $4 million to settle SEC claims that it and three former executives misled investors for nearly a year about regulatory roadblocks facing one of its candidates. Read More
The FDA issued a complete response letter for Newron Pharmaceuticals’ Parkinson’s disease adjunctive therapy Xadago, requesting clinical evaluations of abuse liability and dependency. Read More
The FDA has put the brakes on approving Opko’s secondary hyperparathyroidism candidate Rayaldee, citing third-party manufacturer deficiencies that resulted in a Form 483. Read More
The FDA has sped up its review time of new drugs markedly in the last five years, decreasing its average time for a decision from 21 months to 10 months in 2015, according to a new report. Read More
French authorities are calling for the withdrawal of Anuh Pharma’s GMP certificate after an inspection turned up 24 alleged GMP deficiencies. Read More
A House committee is pressing the FDA on how it’s dealing with drug adulteration for economic reasons, citing the infamous 2008 heparin contamination scandal that killed at least 81 and infected hundreds more as a prime example. Read More
A non-profit group is pressing the National Institutes of Health to bypass the patent rights of a drugmaker in a bid to lower the drug’s price, marking at least the third time the group has attempted this. Read More