Following a late-cycle review meeting with the U.S. FDA in September and the agency’s decision to skip the advisory committee meeting, expectations were high heading toward the PDUFA date for Applied Therapeutics Inc.’s priority NDA for govorestat in galactosemia. So the complete response letter issued by the FDA just ahead of the Nov. 28 PDUFA date, citing deficiencies in the clinical application, caught nearly everyone off guard.
PTC Therapeutics Inc. said a “highly competitive process with several parties involved” led to the deal centered on the firm’s Huntington’s disease program with Novartis AG, an arrangement that brings $1 billion up front along with as much as $1.9 billion in development, regulatory, and sales milestone rewards.
Our immune cells are not just “defenders” against deadly viruses and pathogens but also a great balancer for tissue homeostasis. For neurological disorders, understanding the neuro-immune axis could be key to treating previously untreatable conditions such as autism spectrum disorder, according to Jun R. Huh, professor of immunology at Harvard Medical School.
The U.S. District Court for the Northern District of California ordered Lorik Papyan, who pleaded guilty three years ago to one count of unlicensed wholesale distribution of prescription drugs, to pay Gilead Sciences Inc. nearly $32 million in restitution to cover lost profits due to a counterfeit HIV drug scheme he was involved in.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axsome, Cognition, Genentech, Maat, S. Biomedics, Urogen.
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