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  • Live discussion to assess how US midterm elections could reshape biopharma policy
    Drew Armstrong, executive editor of PharmaFDA+, announced a live webcast at 1:30 pm ET on November 3, 2026 to discuss the impact of the US midterm elections on biotech and pharma. The program will…
    Endpoints · 5d agoNeutral↗ source
  • FDA grants tentative approval for Dr. Reddy’s generic HIV prevention shot, expanding access in low- and middle-income countries
    The U.S. Food and Drug Administration has issued a tentative approval for Dr. Reddy’s Laboratories to produce a generic version of a leading HIV prevention medicine. This decision follows months of…
    STAT · 6d agoApprovalPositive↗ source
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  • New York records first measles death in three decades as vaccination rates slip
    A child in rural northern New York died after contracting measles, marking the first measles-related death in the state in 30 years, officials said. The death comes as U.S. vaccination coverage ha…
    STAT · 6d agoNegative↗ source
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 6d agoRegulatoryNeutral↗ source
  • First U.S. bird flu death of 2026 reported in Washington state after cattle exposure
    A person in Washington state died from complications of avian influenza, according to the Associated Press. It is the first bird flu death in the United States this year. The case follows recent r…
    STAT · 6d agoNegative↗ source
  • Merck KGaA sells its CDMO business and US sites to Lonza
    Merck KGaA announced it will divest its contract development and manufacturing organization (CDMO) operations, transferring ownership of five U.S. manufacturing facilities to Lonza. The transactio…
    Endpoints · 6d agoDealNeutral↗ source
  • Compass Pathways leads race for first psychedelic drug approval, non-profit rivals
    Compass Pathways is widely viewed as a leading candidate to bring the first psychedelic medicine to market. The company has advanced its therapy through clinical development and is positioned near…
    STAT · 6d agoNeutral↗ source
  • Midterm elections could reshape health policy, Medicare Advantage and insurance, STAT analysis says
    STAT's D.C. Diagnosis newsletter looks at how the upcoming midterm elections may influence health policy, Medicare Advantage programs and health insurance markets. With record early voting turnout…
    STAT · 6d agoNeutral↗ source
  • FDA and CMS seek state partnerships to shape health AI regulations and liability protections
    The Food and Drug Administration and the Centers for Medicare & Medicaid Services are planning to work with state governments to develop coordinated rules for artificial intelligence used in health…
    STAT · 6d agoRegulatoryNeutral↗ source
  • Bayer CEO says company is negotiating a most-favored-nation trade pact with US administration
    Bayer chief executive Bill Anderson announced the drugmaker is actively pursuing a most-favored-nation (MFN) agreement with the United States. The comment signals that Bayer is in talks with the T…
    Endpoints · 6d agoRegulatoryNeutral↗ source
  • Pfizer CEO says Democratic gains unlikely to alter Trump-era MFN pricing agreements
    Pfizer chief Albert Bourla told reporters that he does not anticipate any changes to the most‑favored‑nation pricing arrangements that were put in place under the Trump administration, even if the…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Vertex, ahead of FDA decision, calms fears surrounding kidney drug
    On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to Vertex’s future.
    BioPharma Dive · 5d agoEarningsNeutral↗ source
  • Novartis ends discovery-stage collaboration with BioArctic amid broader biotech updates
    Novartis announced it is terminating its discovery-stage partnership with Swedish biotech BioArctic. The decision ends joint work that was focused on early‑stage research. BioArctic is best known…
    Endpoints · 6d agoNeutral↗ source
  • Mortality rates remain higher in states that supported Trump, highlighting political health divide in 2024
    The UCSF team behind the article notes that health care ranks as the third most important issue for voters in the 2026 midterm election cycle. They found that, after adjusting for age differences,…
    STAT · 6d agoNeutral↗ source
  • Endpoints Announces Second Annual Health Tech Day with Virtual Sessions
    On Thursday, Endpoints will hold its second Health Tech Day, an event that brings together leaders in digital health. Lydia Ramsey Pflanzer, the deputy editor, says she looks forward to traveling…
    Endpoints · 6d agoNeutral↗ source
  • Physician finds meditation boosts resilience and patient care after intense trauma cases
    The author, an ophthalmologist at Legacy Devers Eye Institute, attended a meditation retreat in the Santa Cruz Mountains last fall. He describes staying awake through dawn as part of the retreat,…
    STAT · 6d agoPositive↗ source
  • 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 · 7d 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 · 6d agoDealPositive↗ source
  • 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 · 7d 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 · 7d agoPositive readoutNeutral↗ source
  • Karyopharm files for Chapter 11 and plans auction with Gamida Cell parent Ayrmid as lead bidder
    Karyopharm Therapeutics, a cash-strapped cancer drugmaker, announced a Chapter 11 filing on Monday and will conduct a court-supervised auction of the company. Ayrmid, the parent of cell-therapy co…
    BioPharma Dive · 6d agoDealNegative↗ source
  • AstraZeneca outlines restructuring as earnings show cost cuts, while Alnylam slides and Regeneron posts record quarter
    AstraZeneca said it will redeploy resources through a new restructuring program aimed at cutting costs while staying on track to hit its long‑term revenue goal of $80 billion by 2030. The company h…
    BioPharma Dive · 7d agoEarningsNeutral↗ source
  • FDA issues final guidance on potency assurance for cell and gene therapy manufacturers
    The FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
    fda press · 7d agoRegulatoryNeutral↗ 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 · 7d 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 · 6d agoNegative↗ source