The World Health Organization announced it has created an international committee consisting of 18 members that will establish guidelines relevant to editing human DNA. The group's main goal "will be to advise and make recommendations on appropriate governance mechanisms for human genome editing," the WHO said.
The FDA accepted under priority review status Harmony Biosciences' new drug application for pitolisant, which is being developed as a treatment for adult patients with cataplexy or excessive daytime sleepiness and narcolepsy.
The FDA has issued a complete response letter to Motif Bio for its acute bacterial skin and skin structure infection drug iclaprim. The agency asked Motif for more data to evaluate the risk of liver toxicity.
Miraca Holdings subsidiary Fujirebio Diagnostics' Lumipulse G β-Amyloid Ratio quantitative in vitro diagnostic test for Alzheimer's disease has been granted breakthrough device status by the FDA.
Safe Medical Design has secured FDA clearance to commercialize its Signal Catheter in the US. The urinary catheter features a design that can lower the odds of urethral trauma as a result of premature balloon inflation during placement.
The FDA has warned a California physician to stop marketing the Pocket Protector, an unapproved implant he is marketing to prevent and treat capsular contracture. The device, which has been advertised online and through promotional videos, is a polymer pouch bonded with a silicone rubber cement that is implanted inside the breast pocket during augmentation. The FDA noted the physician's manufacturing site is "inadequate" for a sterile device.
Sarepta Therapeutics' marketing application for Duchenne muscular dystrophy drug SRP-4053, or golodirsen, was accepted by the FDA for review. The agency set a PDUFA date of Aug. 19.
CorMedix has been in discussions with the FDA regarding its plan to file a new drug application for its catheter lock solution Neutrolin for use in end-stage renal disease patients undergoing hemodialysis. The FDA is requesting a comprehensive analysis of the full dataset that will be finished in the coming months because CorMedix only submitted preliminary data from its late-stage trial, which showed that treatment with Neutrolin resulted in a 72% reduction in the risk for catheter-related bloodstream infections compared with heparin.
Arvelle Therapeutics, a recent spin-out from Axovant Sciences, has licensed European rights to SK Biopharmaceuticals' anti-epileptic drug cenobamate.
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