The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June. Read More
To the chagrin of some and the joy of others, the U.S. Supreme Court denied cert to Teva Pharmaceuticals USA Inc. v. Glaxosmithkline May 15, leaving standing a split Federal Circuit decision that could threaten the use of FDA-approved label carve-outs, or so-called skinny labels, for generics and biosimilars. Read More
With much-awaited readouts from their broad oncology-focused collaboration due later this year, Arcus Biosciences Inc. and Gilead Sciences Inc. have decided to expand efforts into the inflammatory disease space via an early stage research agreement that could be worth as much as $1 billion. Terms include a $35 million up-front payment to Arcus, which is making its first move beyond oncology. Read More
Nido Biosciences Inc. emerged from stealth by unveiling $109 million in series A and B equity funding and a clinical-stage program in spinal and bulbar muscular atrophy. Read More
Angelini Pharma SpA and JCR Pharmaceuticals Co. Ltd. signed an exclusive worldwide agreement for the development and commercialization of biologic therapies for epilepsy based on the J-Brain Cargo technology. Read More
Regulatory T-cell specialist Dualyx NV has closed a €40 million (US$43.5 million) series A to progress the lead autoimmune disease program to the clinic and to take forward two other Treg-based therapies. The company brings together expertise in antibody design with understanding of the role Tregs play in supressing the immune response to maintain homeostasis and self-tolerance, preventing autoimmunity. Read More
Investigators have identified a second individual who remained cognitively normal into his late 60s despite having the PSEN1 E280A mutation, which causes a familial version of early-onset Alzheimer’s disease (AD). The likely source of protection, a mutation in a gene called Reelin, is distinct from the protective mechanism identified in the first case of an individual who was protected from the effects of PSEN1 E280A. That case was reported in 2019. Read More
Nearly a year and a half after Francis Collins stepped down as director of the U.S. NIH, President Joe Biden announced May 15 his intent to nominate Monica Bertagnolli as the next NIH director. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Celcuity, Innoviva, Kintor, Neurocentrx, Neurocrine, Pfizer, Qilu, Sanofi, Sofie. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ani, ARS, Bloomsbury Genetic Therapies, Byondis, Clearmind, Decibel, Hefei Tianhui, Immpact, Innovent, Lianbio, Novavax, Nuvectis, Oramend, Pyxis, Regeneron, Sisaf. Read More
