Weighing in on the marketing exclusivity provided by the Orphan Drug Act, the U.S. Court of Appeals for the District of Columbia Circuit said the FDA didn’t act beyond its statutory authority when it approved Avadel CNS Pharmaceuticals plc’s narcolepsy drug, Lumryz, for marketing during the exclusivity period granted to Jazz Pharmaceuticals plc’s Xywav, even though both drugs contained the same active ingredient, sodium oxybate, and were approved for the same disease or condition.
Edgewise Therapeutics Inc. CEO Kevin Koch speculated that “perhaps a different environment at the FDA” from four months ago led to reviewers’ caution on sevasemten, his firm’s fast skeletal myelin inhibitor for Becker muscular dystrophy and Duchenne muscular dystrophies.
Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder offered through the Perth Clinic.
Kymera Therapeutics Inc. found itself juggling partnerships by bringing one on board while going to the development bench in another. Kymera and Gilead Sciences Inc. will collaborate on a molecular glue degrader program that targets cyclin-dependent kinase 2 in solid tumors, including breast cancer.
Transthera Sciences Inc. debuted on the Hong Kong stock exchange June 23 with a HK$200.95 million (US$25.6 million) IPO, becoming the latest in a string of mainland Chinese biopharmaceutical firms to turn to the Hong Kong market for capital.
Avata Biosciences Holdings Ltd. and Oceanus Bio Inc. have inked a drug discovery and development deal worth up to $95 million for two of Avata’s cannabidiol compounds.
Shanghai Yao Yuan Biotechnology Ltd., also known as Drug Farm, is advancing a portfolio of immune-modulating therapies for various indications including hepatitis B virus, hepatocellular cancer and a relatively new rare genetic disease called ROSAH, an acronym for retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and headache.
Transthera Sciences Inc. debuted on the Hong Kong stock exchange June 23 with a HK$200.95 million (US$25.6 million) IPO, becoming the latest in a string of mainland Chinese biopharmaceutical firms to turn to the Hong Kong market for capital.
Hitting the primary endpoint on Compass Pathways plc’s Comp005 study of synthetic psilocybin, which the company billed as the first classic psychedelic to report phase III efficacy data, produced only a shrug from investors.
Shanghai Yao Yuan Biotechnology Ltd., also known as Drug Farm, is advancing a portfolio of immune-modulating therapies for various indications including hepatitis B virus, hepatocellular cancer and a relatively new rare genetic disease called ROSAH, an acronym for retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and headache.
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