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  • Opinion: How a controversial rule could hurt the NIH’s ability to manage risk
    The proposed rule could “weaken the NIH’s benign influence over research risks,” writes Doni Bloomfield.
    STAT · 3d ago↗ source
  • Opinion: Science and the public are learning the wrong lessons from Covid
    “Post-pandemic polarization threatens to lock our memories into attractive, untrue conclusions that will leave us unprotected next time,” write Marc Lipsitch and Sara Cody.
    STAT · 3d ago↗ source
  • STAT+: Makers of rare disease drugs seek exemption from Trump’s price-cut pilots
    A coalition of biotech firms is lobbying to exclude orphan drugs from new federal pilot programs aimed at lowering Medicare drug costs.
    STAT · 3d ago
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  • Agios says adios to sickle cell program over lackluster phase 2 data
    A phase 2 study of Agios Pharmaceuticals’ next-generation pyruvate kinase activator has failed to support continued development in sickle cell disease, leading the company to ax an indication for t…
    Fierce Biotech · 3d ago↗ source
  • Novartis drops phase 2 radioligand therapy, but CEO’s commitment to modality ‘unchanged’
    Novartis has dropped a phase 2-stage radioligand therapy after the candidate disappointed in the clinic.
    Fierce Biotech · 3d ago↗ source
  • Indian generics maker Lupin seeds US spinout Kaveri with cash, clinical-phase cancer assets
    Lupin has spun out two clinical-phase cancer drug candidates to create Kaveri Therapeutics, a U.S.-based startup that plans to raise cash for further development. Kaveri’s programs hit targets purs…
    Fierce Biotech · 3d ago↗ source
  • Roche taps Foundation Medicine’s chief as new North America Diagnostics lead, creates new commercial role
    Dan Malarek is leaving his role as chief executive of Roche’s sequencing subsidiary Foundation Medicine as he takes up the mantle as President and CEO of Roche Diagnostics North America.
    Fierce Biotech · 3d ago↗ source
  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 3d ago↗ source
  • FDA cites companies for CGMP violations, informed consent failure
    <p>The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing t…
    raps · 3d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    <p>The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act,…
    raps · 3d ago↗ source
  • FDA still focused on lettuce supplier as source of parasite, despite faulty test result
    The FDA said Monday it is still focused on lettuce from Taylor Farms as the source of a multistate outbreak of a diarrhea-causing parasite, despite a faulty test result.
    STAT · 4d ago↗ source
  • UnitedHealth Group lays out progress in AI push
    After announcing a hefty investment in AI earlier this year, UnitedHealth laid out how it's using the technology across its business in a quarter that landed better than expected. The health insu…
    Endpoints · 4d ago↗ source
  • House lawmakers back trade probe of China biotech, sequencing
    At least 10 House lawmakers are backing a US trade panel’s probe of China’s biotech sector and related pricing practices, encouraging future executive action. In a letter sent to Secretary of the…
    Endpoints · 4d ago↗ source
  • Samsung Bio to step into peptides in $1.8B buy for PolyPeptide
    Samsung Biologics is set to branch out to peptide ingredient manufacturing with plans to buy Swiss CDMO PolyPeptide for $1.8 billion in cash. The purchase, announced Monday, would be the Korean ...
    Endpoints · 4d ago↗ source
  • Anthropic's life sciences plans: Mystery programs, Nobel hires, M&A and big ambition
    A year ago, Anthropic’s life sciences plans were basically just a blog post by its CEO. In late 2024, Dario Amodei wrote a 13,000-word memo naming biology and neuroscience among his ...
    Endpoints · 4d ago↗ source
  • Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab
    Scribe writes in $96M IPO: The gene editing biotech expects net proceeds of about $96 million if it prices its Nasdaq listing at $14 per share, the midpoint of the ...
    Endpoints · 4d ago↗ source
  • J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal
    Johnson & Johnson and AbbVie, the two pharma giants already in the psychedelic space, also eyed AtaiBeckley, according to a source familiar with the situation, but didn’t make an offer before E…
    Endpoints · 4d ago↗ source
  • ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong
    Axiom Biosciences intends to pursue an IPO on the Hong Kong Stock Exchange (HKEX), followed by a co-listing on the Nasdaq—a strategy the company claims is the first U.S. biotech to use.
    Fierce Biotech · 4d ago↗ source
  • STAT+: The next step of site-neutral, and a fiery PBM hearing
    Medicare proposes to reduce payments to hospitals for certain drugs and imaging services.
    STAT · 4d ago↗ source
  • STAT+: A most-wanted fugitive appears to have been secretly working as a biotech executive
    A former doctor accused of sexual assault but on the run for 20 years appears to have been living a secret life as a biotech executive.
    STAT · 4d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a telehealth firm and patient safety, PBMs overcharging, and more
    Some former employees say telehealth company LifeMD has sought to maximize the volume of GLP-1 prescriptions at the expense of patient safety
    STAT · 4d ago↗ source
  • HHS vaccine committee quietly gets new charter
    Lax clinical oversight for online GLP-1 prescriptions, proposed financial help for people who want to quit smoking, and more health news
    STAT · 4d ago↗ source
  • Genetic medicine luminaries launch new center for personalized therapies
    A team of veteran scientists from elite institutions has come together to form a new center dedicated to the crafting of personalized genetic medicines, adding to the growing list of similar effort…
    Fierce Biotech · 4d ago↗ source
  • UK biotech VC funding rebounds and reaches record high
    UK biotechs attracted more venture capital funding in the second quarter of 2026 than in any full year since 2022, in a sign that the country is amid a fundraising revival as investors get attracti…
    Endpoints · 4d ago↗ source
  • Bristol Myers, Nvidia say they'll build 'most powerful' AI supercomputer in pharma
    Bristol Myers Squibb said Monday it will build "the most advanced and energy-efficient AI" supercomputer system in the biopharma industry, deepening its relationship with Nvidia. The New Jersey-h…
    Endpoints · 4d ago↗ source