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  • Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
    Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the…
    BioSpace · 3d ago↗ source
  • STAT+: Advocates say federal funding is being cut from groups fighting HIV
    The administration is shifting some funding to states, but community groups are set to lose out.
    STAT · 3d ago↗ source
  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.<br>
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Fierce Biotech · 3d ago
↗ source
  • Is there an exodus underway at Epic?
    In this edition of STAT Health Tech: executive departures at Epic Systems, new CEO takes over at Nabla, and more health tech news.
    STAT · 3d ago↗ source
  • STAT+: Broad Institute, partners unveil new initiative to develop gene therapies for rare diseases
    The Broad Institute, Boston Children’s Hospital, and Maine’s Jackson Laboratory announced a collaboration to develop rare disease gene therapies.
    STAT · 3d ago↗ source
  • STAT+: Anthropic deepens work with rare disease drugs
    Novo Nordisk sues Eli Lilly over GLP-1s, Medicare pricing plans, and more biotech news from The Readout
    STAT · 3d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Novo suing Lilly over ‘deceptive’ ads, a fugitive’s secret life in biotech, and more
    Novo Nordisk sued Eli Lilly for allegedly running “deceptive” ads to make its obesity and diabetes drugs appear more effective
    STAT · 3d ago↗ source
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    BioSpace · 3d ago↗ source
  • ‘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
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 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
  • Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
    If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…
    BioSpace · 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.
    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
  • Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
    Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
    BioSpace · 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