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  • 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
  • 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
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  • 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
  • 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 · 29d 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
  • 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
  • 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 · 29d 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 · 29d 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 · 29d 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 · 29d agoNeutral↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1mo ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.
    raps · 1mo ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 1mo ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any…
    raps · 1mo ago↗ source
  • Graham’s death from aortic dissection raises questions about preventing the rare disorder
    When the body’s most important blood vessel tears from the inside, it’s a medical emergency that can be years in the making.
    STAT · 1mo ago↗ source
  • Graham’s death from aortic dissection raises questions about preventing the rare disorder
    When the body’s most important blood vessel tears from the inside, it’s a medical emergency that can be years in the making.
    STAT · 1mo ago↗ source
  • STAT+: At key hearing, Kennedy’s ouster of former CDC director looms over nominee to replace her
    Erica Schwartz and Sean Kaufman navigated tough questions about vaccines, political independence, and pushing back on RFK Jr.
    STAT · 1mo ago↗ source
  • FDA acting chief walks back Makary's practice of policymaking through journals
    The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face f…
    Endpoints · 1mo ago↗ source
  • Senate committee questions CDC pick on political interference over vaccines
    Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday. The CDC has been witho…
    Endpoints · 1mo ago↗ source
  • STAT+: New study untangles how Epstein-Barr viral infection triggers immune response in multiple sclerosis
    A new study claims to have uncovered how Epstein-Barr virus launches immune responses seen in people with multiple sclerosis.
    STAT · 1mo ago↗ source