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  • FDA grants tentative approval for generic HIV prevention shot, boosting access in low-income nations
    After months of anticipation, the U.S. Food and Drug Administration issued a tentative approval for Dr. Reddy’s Laboratories to produce a generic version of lenacapavir, the long‑acting injectable…
    STAT · 12d agoRegulatoryPositive↗ source
  • WuXi Biologics and Fresenius strike major deal for up to 37 biosimilars over the next decade
    WuXi Biologics and German drugmaker Fresenius have agreed to collaborate on the development and manufacturing of up to 37 biosimilar medicines over the next ten years. The agreement is described a…
    Endpoints · 12d agoDealPositive↗ source
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  • Four major drugmakers allegedly paid tens of millions to Russian middlemen for lifesaving drugs, limiting patient access
    Four large pharmaceutical companies are accused of funneling tens of millions of dollars to Russian intermediaries to deliver essential medicines to government agencies, according to a report by th…
    STAT · 12d agoRegulatoryNegative↗ source
  • Kymera Therapeutics to unveil mid‑stage eczema trial data, aiming to challenge Dupixent
    Kymera Therapeutics, a Massachusetts‑based biotech, is set to release data from its mid‑stage clinical trial of KT‑621 in eczema before the end of 2026. The trial results are being closely watched…
    STAT · 13d agoPositive readoutNeutral↗ source
  • U.S. Health Care System's Economics Are Broken, Says Ascendiun CEO
    Paul Markovich, president and CEO of Ascendiun, argues that the economics of the United States health care system are fundamentally broken. He recounts meeting a healthy, active man in his early 6…
    STAT · 13d agoNegative↗ source
  • Washington resident dies after bird flu infection linked to dairy cattle exposure
    A resident of Yakima County, Washington, died from complications of avian influenza after being exposed to infected cattle at a dairy farm. Health officials said the infection was the H5N1 strain,…
    STAT · 12d agoNegative↗ source
  • FDA sets May 1 decision deadline for UniQure’s Huntington’s disease gene therapy after advisory committee meeting
    The U.S. Food and Drug Administration announced that it has set a review date and scheduled an advisory committee meeting for UniQure’s gene therapy aimed at treating Huntington’s disease. The age…
    Endpoints · 12d agoRegulatoryNeutral↗ source
  • FDA places Bright Minds seizure drug BMB-101 on partial hold over mouse toxicity, shares plunge
    The U.S. Food and Drug Administration issued a partial clinical hold on BMB-101, an experimental seizure treatment from Bright Minds Biosciences, after regulators identified toxicity concerns in pr…
    Endpoints · 12d agoRegulatoryNegative↗ source
  • Woman travels to Albania for experimental mitochondrial replacement therapy amid global fertility industry concerns
    A STAT reporter detailed a case of a woman named Heidy Willis who, after multiple failed IVF cycles, sought an experimental fertility option abroad. Willis traveled to Albania to undergo mitochond…
    STAT · 13d agoNegative↗ source
  • Women travel abroad for unproven three-parent IVF marketed to older patients
    STAT investigators found that women are journeying thousands of miles to undergo a mitochondrial‑replacement IVF procedure that is promoted as a fertility option for older patients, even though the…
    STAT · 13d agoNegative↗ source
  • AbbVie signs up to $757M deal with Beijing's Brise Pharma for two preclinical migraine candidates
    AbbVie announced a discovery and commercialization agreement with Brise Pharma, a Beijing-based biotech company. The partnership covers two preclinical migraine programs and is valued at up to $75…
    Endpoints · 12d agoDealNeutral↗ source
  • Midterm voters weigh health-care costs as urgent-care visits billed like ERs
    The upcoming midterm elections will see tens of millions of voters consider health‑care affordability, especially those whose coverage comes through their employers. The article points out that ri…
    STAT · 12d agoNegative↗ source
  • Karyopharm Therapeutics to merge with Ayrmid as it enters bankruptcy
    Karyopharm Therapeutics, a commercial-stage biotech focused on blood cancers, announced it will pursue a merger with Ayrmid while navigating a bankruptcy process. The move aims to combine the two c…
    Endpoints · 12d agoDealNeutral↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 13d agoDealNeutral↗ source
  • Study finds psilocybin does not produce lasting anxiety or depression relief in mice
    Five Bay Area laboratories joined forces to examine whether a single dose of psilocybin could produce lasting reductions in anxiety and depression-like behavior in mice. The study measured behavior…
    STAT · 12d agoNegative readoutNegative↗ source
  • Cancer can be treated safely during pregnancy, says maternal-fetal specialist
    Elyce Cardonick, a maternal-fetal medicine physician and founder of the Cancer and Pregnancy Registry, argues that pregnant cancer patients are often urged to terminate their pregnancies even thoug…
    STAT · 13d agoPositive↗ source
  • STAT calls for input on mitochondrial replacement therapy used in fertility tourism
    STAT is asking patients and clinicians to share their experiences with mitochondrial replacement techniques (MRT), sometimes called three-parent IVF, which are being marketed as a fertility option…
    STAT · 13d agoNeutral↗ source
  • Midterm election outcomes could reshape U.S. health policy, experts say
    The article notes that regardless of the results, the upcoming midterm elections will have broad effects on the U.S. health system, according to more than two dozen policymakers, lobbyists and expe…
    STAT · 15d agoRegulatoryNeutral↗ source
  • Halloween edition of Endpoints Weekly teases Anthropic biotech acquisition and Jake Van Naarden’s deal strategy
    The latest Endpoints Weekly arrives with a Halloween theme, offering a light‑hearted introduction to the issue’s content. Among the topics highlighted is Anthropic’s purchase of a one‑person biote…
    Endpoints · 15d agoNeutral↗ source
  • Aspen Neuroscience and Bambusa raise $310M combined in IPOs
    Aspen Neuroscience, a biotech focused on cell therapy for Parkinson's disease, announced it will raise about $141 million through its initial public offering scheduled for Friday. Bambusa, a start…
    Endpoints · 16d agoDealPositive↗ source
  • Sanofi plans to pursue higher European drug prices rather than delay product launches under Trump policy
    Sanofi indicated it may seek higher drug prices in Europe as part of a deal related to President Trump's pricing policies. Unlike other major European pharma companies that have warned the policie…
    Endpoints · 15d agoNeutral↗ source
  • Gilead places CAR-T program on partial hold after ICANS cases; Agios delays PDUFA submission
    Gilead announced a partial clinical hold on its CAR-T therapy after several patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). The hold will pause enrollment and…
    Endpoints · 15d agoRegulatoryNegative↗ source
  • AstraZeneca hints restructuring may trim R&D budget and move trials to emerging markets
    AstraZeneca's chief executive Pascal Soriot told journalists that the company's new restructuring program could lead to cost reductions in research and development and may see some clinical trials…
    Endpoints · 15d agoNegative↗ source
  • Podcast examines Merck and Moderna’s mRNA cancer vaccine data presented at ESMO
    The latest episode of STAT’s biotech podcast "The Readout LOUD" focused on the mRNA cancer vaccine being co‑developed by Merck and Moderna, using data shown at the European Society for Medical Onco…
    STAT · 16d agoNeutral↗ source
  • Sanofi says no major restructuring despite upcoming Dupixent patent expiration
    Sanofi's new chief executive, Belén Garijo, said after six months in charge that the company will not embark on a major overhaul of its business or research pipeline. The comment was made as the b…
    Endpoints · 16d agoNeutral↗ source