Windtree Therapeutics Inc. is out-licensing China rights for phase III-ready heart failure candidate istaroxime to Lee’s Pharmaceutical Ltd. for $138 million, plus royalties. Lee’s, of Hong Kong, plans to begin a phase III study for istaroxime in acute heart failure in greater China, while Windtree, of Warrington, Pa., will conduct a global trial in cardiogenic shock, a form of sudden heart failure. Windtree reported positive phase II data in April 2022 that tested istaroxime in cardiogenic shock, which happens when the heart cannot pump enough blood and oxygen to vital organs. Read More
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101. Read More
After the U.S. FDA granted clearance in March 2023, sales began promptly of Acadia Pharmaceuticals Inc.’s new Rett syndrome therapy, Daybue (trofinetide), and questions during the recent J.P. Morgan Healthcare Conference in San Francisco had to do with – among other matters – sales guidance from the firm, which is hardly alone in seeking treatments for the disease. Other players include Anavex Life Sciences Corp., Neurogene Inc. and Taysha Gene Therapies Inc. Read More
With one approved myosin inhibitor on the market and another coming up fast, researchers such as those at Tenaya Therapeutics Inc. are casting for new strategies to treat hypertrophic cardiomyopathy (HCM). Read More
U.S. Sen. Bernie Sanders (I-Vt.), chair of the Health, Education, Labor and Pensions Committee, is not taking no for an answer after the CEOs of Johnson & Johnson (J&J) and Merck & Co. Inc. declined an invitation to appear before the committee to explain their U.S. drug prices. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Adagene, Arcus, Biomica, CNS, Galderma, Gilead, Immunity, Kineta, Leap, Lisata, Maia, Petros, Regenxbio. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Enlivex, Hyloris, Nurix, Pleco, Tarsier, Utility, Vertex. Read More
