PharmAsia News Business Bulletin
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Another Class I Recall For Datascope’s Aortic Balloon Pumps
Datascope/Getinge has initiated another recall of its Intra-Aortic Balloon Pumps, this time for a potentially faulty cable connection.
Karuna Three-For-Three As Another KarXT Schizophrenia Trial Hits Primary Endpoint
The company is on track for a mid-2023 FDA filing, while executives suggested that they would likely pursue partnership for commercialization of the drug in Europe.
Biogen/Ionis’ Tofersen: US FDA Considering Both Accelerated And Regular Approval In ALS
FDA seeks advisory committee input on whether there is ‘convincing evidence’ to support regular approval for treatment of SOD1-ALS patients even though lone Phase III trial failed its primary endpoint; companies filed for accelerated approval on the basis that a reduction in plasma neurofilament light chain is reasonably likely to predict clinical benefit.