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ARTICLE | Product Development

July 23 Quick Takes: Priority Review for Aurinia; plus Jazz, CymaBay, Biogen, Vertex, Grünenthal, Mesoblast, BMS and Genfit

July 24, 2020 2:04 AM UTC
Updated on Jul 24, 2020 at 2:11 PM UTC

Priority Review for Aurinia’s lupus nephritis therapy
FDA accepted and granted Priority Review to an NDA for voclosporin from Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH; TSX:AUP) to treat lupus nephritis. The PDUFA date for the immune-suppressing, IL-2-blocking calcineurin inhibitor is in January.

FDA approves Jazz’s narcolepsy therapy
FDA approved Xywav from Jazz Pharmaceuticals plc (NASDAQ:JAZZ) to treat cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients seven years of age and older. The GABA B receptor modulator is an oral solution containing a mixture of oxybate salts with 92% less sodium than the company’s Xyrem sodium oxybate. Jazz is also evaluating Xywav as a treatment for idiopathic hypersomnia in adults...

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