Xyrem gains daytime claim
Executive Summary
FDA clears Jazz Pharmaceuticals' Xyrem (sodium oxybate) for treatment of excessive daytime sleepiness in patients with narcolepsy Nov. 18. Xyrem was previously approved for cataplexy in narcolepsy patients. The firm has said that it would seek a general narcolepsy indication; cataplexy and EDS are the two primary symptoms of narcolepsy (1"The Pink Sheet" April 25, 2005, p. 26)...
You may also be interested in...
Jazz Pharma Acquires Orphan Medical; Plans Variations On Xyrem
Jazz Pharmaceuticals is likely to experiment with new formulations of the narcolepsy agent Xyrem (sodium oxybate) after acquiring Orphan Medical
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.