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  • Advanced analytics enable up to 12% cut in control animal use while keeping study rigor
    The control group is a cornerstone of nonclinical safety studies, providing the baseline needed to separate a drug’s effects from normal biological variation. Researchers are now applying virtual…
    Fierce Biotech · 7d agoPositive↗ source
  • AbbVie halts development of livmoniplimab after deeming benefit limited
    AbbVie announced it is discontinuing the phase 2 development of its monoclonal antibody livmoniplimab (ABBV-151) after concluding the drug is unlikely to outperform existing therapies. The drug wa…
    Fierce Biotech · 7d agoNegative↗ source
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Stakeholders submit over 500 comments urging FDA to shape regulation of generative AI medical devices
Over 500 comments have been filed in response to the FDA's discussion paper on generative AI-enabled medical devices. The feedback reflects a wide range of viewpoints. Some participants recommend…
raps · 7d agoRegulatoryNeutral↗ 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d agoNeutral↗ source
  • GE HealthCare launches Allia Celeo ceiling-mounted AI image guidance system at TCT 2026
    GE HealthCare introduced a new imaging product called Allia Celeo. The system is mounted on the ceiling and uses artificial intelligence to guide image acquisition during procedures. The debut…
    Fierce Biotech · 7d agoPositive↗ 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 · 7d 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 · 7d agoPositive↗ source
  • Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 7d ago↗ 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 · 8d agoRegulatoryPositive↗ source
  • FDA places uniQure’s Huntington’s gene therapy in priority review, targeting May 2027 approval
    The U.S. Food and Drug Administration has accepted uniQure’s filing for its Huntington’s disease gene therapy and placed the product under priority review, a step that could accelerate a decision b…
    Fierce Biotech · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d agoEarningsNeutral↗ 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 · 8d agoNegative↗ source
  • InventisBio's Phase 3 Trial Shows Nomelcitinib Achieves Over 70% PASI-90 Response in Chinese Psoriasis Patients
    InventisBio, a Shanghai‑based biotech, completed a phase 3 study of its TYK2 inhibitor nomelcitinib in 391 Chinese patients with moderate to severe psoriasis. Participants were randomized to receiv…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • FDA issues final guidance on potency standards for cell and gene therapy developers
    The U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…
    raps · 8d agoRegulatoryNeutral↗ 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 · 8d agoNegative↗ source