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  • Medicare proposes overhaul of payment models for clinical AI and remote patient monitoring
    The Centers for Medicare and Medicaid Services (CMS) has announced a set of proposals aimed at reshaping how Medicare reimburses clinical artificial intelligence tools and remote patient monitoring…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Sanofi sues Pfizer and Moderna over alleged infringement of mRNA delivery patents
    Sanofi has filed a lawsuit against Pfizer and Moderna, accusing the two companies of violating its patents covering lipid nanoparticle technology used to deliver mRNA in vaccines. The French drugm…
    Endpoints · 1mo agoRegulatoryNegative↗ source
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  • Eli Lilly to acquire AtaiBeckley for $2.8 billion, signaling deeper bet on psychedelics
    Eli Lilly announced on Thursday that it will acquire psychedelic drug developer AtaiBeckley. The purchase price is set at $2.8 billion paid upfront. The sizable upfront payment highlights Lilly's…
    Endpoints · 1mo agoDealPositive↗ source
  • Amylyx to read out pivotal endocrine drug study results later this quarter
    Amylyx Pharmaceuticals will read out results later this quarter from a study of a new treatment for a rare endocrine disorder. The drug, avexitide, is being developed to prevent severe, uncontroll…
    STAT · 1mo agoNeutral↗ source
  • CMS proposes new payment framework for clinical software and AI to link reimbursement with patient outcomes
    The Centers for Medicare & Medicaid Services (CMS) has released proposed rules for 2027 that would create a standardized payment structure for clinical software and artificial intelligence tools. T…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Podcast highlights prediction markets entering biotech and Biogen Alzheimer's drug controversy
    The Readout LOUD episode released on July 16, 2026 features hosts Elaine Chen, Adam Feuerstein and Allison DeAngelis. The trio discuss trends shaping biotech, from new obesity treatments to evolvin…
    STAT · 1mo agoNeutral↗ source
  • Kalshi to Offer Prediction Market Bets on Clinical Trials and Regulatory Approvals
    Kalshi, one of the world’s largest prediction‑market exchanges, announced it will start allowing bets on the outcomes of clinical trials and regulatory approvals. The initiative could give investor…
    STAT · 1mo agoNeutral↗ source
  • Kalshi launches prediction markets for clinical trial results and FDA approvals
    Kalshi, a major prediction market exchange, announced it will begin offering markets that let participants bet on the outcomes of clinical trials and on whether drugs will receive FDA approval. Th…
    STAT · 1mo agoPositive↗ source
  • Venom’s hidden potential fuels next wave of peptide medicines beyond GLP-1 weight-loss drugs
    Steve Midway, an associate professor at LSU, argues that many powerful medicines already exist in the venoms of feared creatures, noting that venom contributed to the development of GLP-1 based wei…
    STAT · 1mo agoPositive↗ source
  • Medicaid and SNAP cuts deepen hunger and mental health crises, clinicians warn
    Cole Hanson, a clinical dietitian at a large urban hospital, writes about the direct link he sees between food insecurity and psychiatric emergencies. He recounts a patient who arrived with suicid…
    STAT · 1mo agoRegulatoryNegative↗ source
  • EMA issues guidance to curb microbial contamination in non-sterile medicines; MHRA reports record drug approvals
    The European Medicines Agency has issued new guidance that outlines technical and organisational measures to reduce the risk of microbial contamination in non-sterile pharmaceutical products. The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Senate health committee hears testimony from Trump pandemic preparedness nominee amid daylight-saving debate
    The Senate health committee convened a hearing where the president’s pandemic preparedness nominee provided testimony on readiness measures. Lawmakers also debated proposals to make daylight savin…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps toward AI oversight in healthcare
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines this year than in t…
    raps · 1mo agoRegulatoryNeutral↗ source
  • ADA blocks Diabetes Care editorial on conference controversy, sparking fresh turmoil
    Turmoil at the American Diabetes Association (ADA) has intensified after leaders prevented editors of its flagship journal, Diabetes Care, from publishing an editorial and first-person accounts abo…
    STAT · 1mo agoNegative↗ source
  • Defense Secretary proposes annual testosterone screening for service members, sparking mixed expert reaction
    U.S. Defense Secretary Pete Hegseth announced that service members will have testosterone deficiency testing added to their annual physical exams. The plan targets war-fighters aged 30 and older, w…
    STAT · 1mo agoNeutral↗ source
  • Kelun-Biotech reports first-line success of Merck-partnered ADC sacituzumab tirumotecan in China
    Kelun-Biotech announced that its antibody‑drug conjugate sacituzumab tirumotecan, developed in partnership with Merck, achieved its primary efficacy endpoints when used as a first‑line therapy in a…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Uganda remains silent on Marburg outbreak updates, WHO says
    The World Health Organization noted that Uganda has not provided any new information since it announced a Marburg virus outbreak late last month. WHO officials have sent multiple requests for deta…
    STAT · 1mo agoNeutral↗ source
  • Reporter attends AHA Leadership Summit in Denver to gauge hospital executives' priorities
    The author attended the American Hospital Association’s Leadership Summit in downtown Denver earlier this week. While there, the author handed out ice cream recommendations to attendees. The prim…
    Endpoints · 1mo agoNeutral↗ source
  • Celcuity receives FDA approval for Revtorpyk, a breast cancer therapy, but shares drop nearly 20% amid launch delay concerns
    Celcuity announced that the U.S. Food and Drug Administration cleared its breast cancer drug Revtorpyk for use in combination with hormone therapy and Pfizer's Ibrance in patients with ER-positive,…
    BioPharma Dive · 1mo agoApprovalNegative↗ source
  • Merck's sac-TMT shows promise in Chinese Phase 3 lung cancer trial, may replace chemo
    Merck and its Chinese partner Kelun-Biotech reported that the antibody-drug conjugate sac-TMT slowed disease progression better than a standard chemotherapy regimen in a Phase 3 trial conducted in…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Medicare proposes ban on vendor-provided remote patient monitoring services
    Medicare regulators have proposed a rule that would prohibit vendors from delivering remote patient monitoring services on behalf of physicians, marking a significant policy shift. Remote patient…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Senator Lindsey Graham’s death highlights gaps in detecting aortic dissection
    Senator Lindsey Graham, 71, died on Saturday after suffering an aortic dissection, a sudden tear in the body's main blood vessel that can be fatal. A final death certificate has not yet been relea…
    STAT · 1mo agoNegative↗ source
  • Senate hearing probes CDC nominee Erica Schwartz amid concerns over political pressure from RFK Jr. and Trump
    Senate leaders questioned Erica Schwartz, the administration's nominee to head the CDC, about her ability to resist political pressure during a Wednesday hearing. Lawmakers referenced the earlier…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA acting chief says two journal articles by former commissioner do not represent agency policy
    Acting FDA Commissioner Kyle Diamantas announced that the agency is reversing its earlier position regarding two medical‑journal articles authored by former commissioner Marty Makary. The FDA now…
    Endpoints · 1mo agoRegulatoryNeutral↗ source