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 (VMS) 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. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.  

US Supreme Court says no to skinny label case

To the chagrin of some and the joy of others, the U.S. Supreme Court denied cert today to Teva Pharmaceuticals USA Inc. v. Glaxosmithkline LLC, leaving standing a split Federal Circuit decision that could call into question whether a so-called skinny label induces off-label infringement of a carved-out, patented indication. As part of that decision, Teva must pay GSK $235 million, which is more than three times the total sales of Teva’s generic that references GSK’s heart drug, Coreg (carvedilol), including the sales for non-infringing uses. 

Lucrative Arcus, Gilead alliance expands into inflammatory disease

With much-awaited readouts from their oncology-focused collaboration due this year, Arcus Biosciences and Gilead Sciences Inc. are expanding their work into inflammatory disease via a research agreement worth up to $1 billion. Arcus picks up $35 million up front and will be responsible for initiating research programs against up to four jointly selected targets, with Gilead holding an exercise option at two prespecified time points. Shares of Arcus (NASDAQ:RCUS) were up 9% in midday trading.

Newco news: Nido raises $109M to drug novel targets in neurological disease 

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. The Watertown, Mass.-based firm was established by founding investor 5AM Ventures, through its 4:59 Initiative, which incubates fledgling firms until they are ready for series A financing. Nido Bio’s focus is on leveraging recent insights into the molecular mechanisms underlying neurological diseases to develop small-molecule drugs that restore healthy cell function.

JCR Pharma collaborates with Angelini on biologic therapies for epilepsy 

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 that can penetrate the blood-brain barrier. Therapies developed will target epilepsy. Once preclinical development is complete, Angelini will be granted an exclusive license option to progress potential therapeutic candidates into clinical development and global commercialization, excluding Japan. JCR will receive reimbursement for research expenses and an initial payment, as well as further payments of up to $505.5 million based on development and commercial milestones, plus tiered royalties on net sales. 

Newco news: Autoimmune disease firm Dualyx raises $43.5M in series A  

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. The company is capitalizing on this in the development of multispecific antibodies that selectively expand and activate endogenous Tregs without activating other immune cells. 

Reelin’ in druggable protective pathways with second Alzheimer’s ‘escapee’

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. But both cases converge on a familiar player in AD. In combination, the cases have “opened the door for ... the next generation of therapeutics,” Joseph Arboleda-Velasquez told BioWorld.

Also in the news

Abbvie, Algorithm Sciences, Aligos, ARS, Athenex, Bavarian Nordic, Bionecure, Celcuity, Clearmind, Decibel, Emergent, Ensysce, FSD, Fulcrum, Genelux, GSK, Hillstream, Hoth, Hummingbird, Ikena, Innoviva, Kintor, Lianbio, Locanabio, Melinta, Merck, Neurocentrx, Neurocrine, Novavax, Omass, Pfizer, Pyxis, Qilu, Regeneron, Sandoz, Sanofi, Scynexis, Sofie, Uniqure, Vir, Xediton, Xiamen Amoytop