The FDA has refused to review ozanimod, Celgene’s Phase III potential multiple sclerosis blockbuster. The agency filed a refuse-to-file letter because the drug’s application contained insufficient “nonclinical and clinical pharmacology” sections. Celgene’s stock was down more than 6% in after-hours trading. (STAT)
AstraZeneca is spinning off its autoimmune drugs into an independent $250 million biotech company. The new company’s portfolio will include three clinical and three pre-clinical biological compounds. (Reuters)
The Justice Department will back an Ohio lawsuit that accuses prescription opioid manufacturers, distributors, and dispensers of using misleading marketing to sell the painkillers. Attorney General Jeff Sessions also announced the creation of a task force that will target these companies. “We will use criminal penalties. We will use civil penalties,” he said. (The New York Times)
The FDA has granted Galera Therapeutics breakthrough status for a treatment that aims to reduce the toxic effects of radiation therapy. Data from the company’s Phase IIb clinical trial indicated the intravenous drug mitigates multiple severe side effects of radiation for head and neck cancer patients. (Endpoints)
Boston Children’s Hospital and Klick Health have unveiled a VR platform to help pediatric GI patients visualize their medical findings. The tool, dubbed HealthVoyager GI, enables gastroenterologists to build customized, 3D anatomical models of patients’ endoscopy and colonoscopy findings and show them to patients in VR on a mobile device. (MM&M)
