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849 stories matching this filter · ← front page

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  • ‘We’ve been looking for a novel approach’: Why Novartis CEO ended ADC holdout for $1.5B Myricx deal
    For years, as Big Pharma poured billions into ADCs, Novartis CEO Vas Narasimhan notably stayed on the sidelines. Asked by Fierce during Novartis’ Q2 earnings call, Narasimhan explained why he is en…
    Fierce Biotech · 3d ago↗ source
  • STAT+: Nabla’s new CEO on plan to gain market share in a competitive AI scribe environment
    Ambient scribe developer Nabla said Brian Manning will be the Paris-based company's new CEO as it looks to grow in a highly competitive market.
    STAT · 3d ago↗ source
  • STAT+: Novo Nordisk sues Eli Lilly over GLP-1 drug ads it calls ‘deceptive’
    Novo Nordisk sued Eli Lilly for allegedly running a “deceptive” ad campaign that uses “outdated clinical trials” to make its obesity and diabetes drugs appear more effective.
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STAT · 3d ago
↗ source
  • A renewed push from the right against abortion pills
    The latest on cyclospora, THC sodas at the grocery store, and more health news from Morning Rounds
    STAT · 3d ago↗ source
  • Jupiter enters psychedelics space with $100M deal for PharmAla's MDMA drug
    Jupiter Neurosciences will pay $3.3 million upfront to Canada's PharmAla Biotech for U.S. rights to an MDMA drug to treat neuropsychiatric disorders.
    Fierce Biotech · 3d ago↗ source
  • THC drinks are sold beside sodas, iced tea, and even chocolate milk, often in violation of state laws
    THC drinks, which have exploded in popularity in recent years, are sold in retail stores beside sodas, iced tea, and even chocolate milk, often in violation of state laws.
    STAT · 3d ago↗ source
  • 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↗ source
  • 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 · 3d 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
  • STAT+: Bristol Myers Squibb becomes latest company to claim it’s building pharma’s largest NVIDIA AI supercomputer
    Bristol Myers Squibb is the third drugmaker in nine months to announce it is building the largest AI supercomputer in the life sciences industry.
    STAT · 4d ago↗ source
  • Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trial
    A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints. With a second late-stage study scheduled to report data in October, the biotech is holding off on…
    Fierce Biotech · 4d ago↗ source