Novel approaches are needed to improve anti-inflammatory drug delivery to the brain, particularly to glial cells, in order to reduce neuroinflammation.

Epic Bio (Epicrispr Biotechnologies Inc.) has announced that EPI-321 has been awarded U.S. orphan drug designation for the treatment of facioscapulohumeral muscular dystrophy (FSHD).

The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.

Solid Biosciences Inc. has received FDA clearance of its IND application for SGT-003, the company’s next-generation gene therapy candidate for Duchenne muscular dystrophy (DMD). The planned first-in-human phase I/II trial will enroll pediatric patients with DMD to receive SGT-003 as a one-time intravenous infusion.

In a global deal worth up to $770.5 million in up-front and milestone payments, Stevenage, U.K.-based Autifony Therapeutics Ltd. signed with Dublin-based Jazz Pharmaceuticals plc for two ion channel-targeting programs aimed at finding and developing new drugs for neurological disorders. Autifony will take selected candidates through preclinical development, while Jazz will cover clinical development, manufacturing, regulatory activities and commercialization.