FDA approval of Vumerity (diroximel fumarate), a new therapy for people with multiple sclerosis (MS) offering improved gastrointestinal tolerability over Tecfidera (dimethyl fumarate), marks a win for its co-developers, Biogen Inc. and Alkermes plc, while triggering a $150 million payment from Biogen to its partner to mark the milestone. Biogen will also pay Alkermes a royalty on worldwide sales of the product. Read More
Two phase II stumbles for startup Cyclerion Therapeutics Inc., an Ironwood Pharmaceuticals Inc. spinout, crushed the stock (NADAQ:CYCN), which closed down a steep 79.5% on Wednesday. Read More
Pandion Therapeutics Inc.'s deal with Astellas Pharma Inc. brings as much as $45 million in up-front money and payments related to research and preclinical activities, with potentially more than $750 million in development and commercial milestone rewards to come, plus royalties if products reach the market. Read More
A Chinese study has identified small-molecule compounds that can selectively reduce levels of the mutant Huntingtin (HTT) protein involved in the pathogenesis of Huntington's disease (HD), and possibly other neurodegenerative diseases involving mutant protein accumulation. Read More
Agile Therapeutics Inc. didn't feel much love Wednesday from FDA reviewers who questioned the efficacy of its Twirla birth control patch, but it got a warm embrace from the Bone, Reproductive and Urologic Drugs Advisory Committee, which voted 14-1, with one abstention, that Twirla's benefits outweigh its risks. Read More
MELBOURNE, Australia – Brisbane-based Kira Biotech Pty Ltd. is poised to enter the clinic after raising AU$20 million (US$13.72 million) in series A funding to develop therapies targeting immune system disorders. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
