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  • Why early de-risking is redefining the path to IND
    Lonza explains why early de-risking has become a strategic imperative for biotech teams working to reach IND with confidence.
    Fierce Biotech · 9d ago↗ source
  • Radiopharma maker AdvanCell hauls in $315M for Pluvicto challenger
    AdvanCell raised a $315 million Series D to study a lead-based prostate cancer agent and shore up its US manufacturing of the radioactive treatment. The round marks one of the largest yet for a r…
    Endpoints · 9d ago↗ source
  • STAT+: Celcuity’s breast cancer drug approved, its first
    FDA's new CBER chief promises normalcy, an weight loss drug without GLP-1s, and more biotech news from The Readout
    STAT · 9d ago↗ source
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  • Understanding Agentic AI in Clinical Development
    Earlier this year, my colleague Matt Harrington suggested that clinical leaders should stop asking whether their organizations have an “AI strategy”, not because strategy doesn’t matter, but becaus…
    Fierce Biotech · 9d ago↗ source
  • Deaths from coronary artery disease have fallen, but more progress is within reach
    Managing risk factors is the key to further progress in reducing deaths from coronary artery disease, a new study finds.
    STAT · 9d ago↗ source
  • J&J touts Icotyde prescriptions, but not sales, in first full quarter
    Johnson & Johnson teased some details on Wednesday morning about how the launch of its expected blockbuster Icotyde performed in the second quarter. Without disclosing how much revenue the pl…
    Endpoints · 9d ago↗ source
  • More health workers strike as Ebola cases in Congo exceed 2,000, including 754 deaths
    The number of confirmed cases of Ebola in Congo has reached 2,011, including 754 deaths, making it the the fastest-growing outbreak on record, authorities say.
    STAT · 9d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Biogen Alzheimer’s drug, skyrocketing 340B drug sales, and more
    An Alzheimer’s drug from Biogen slowed cognitive decline in a mid-stage trial at roughly comparable rates as approved medicines
    STAT · 9d ago↗ source
  • Nava Therapeutics emerges with $89M for lipid nanoparticles
    Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company t…
    Endpoints · 9d ago↗ source
  • Braveheart files for IPO to fund Phase 3 of Hengrui's Cytokinetics rival
    Biotechs are sprinting to the IPO queue. In the industry's fourth IPO filing in two weeks, Braveheart Bio is seeking a Nasdaq listing to fuel Phase 3 testing of a cardio drug that could potential…
    Endpoints · 9d ago↗ source
  • Insilico, Bora Pharma reveal plans for AI-driven manufacturing company
    Insilico Medicine and Taiwan-based CDMO Bora Pharmaceuticals are launching a new company with an AI-driven biologics manufacturing platform in a bid to compete with service providers headquartered…
    Endpoints · 9d ago↗ source
  • What to know about the parasitic diarrhea outbreak
    Fallout from the end of ACA subsidies, the FDA CBER acting director "on planet Earth," and more health news from Morning Rounds
    STAT · 9d ago↗ source
  • Veradermics declares first efficacy win in women for hair loss drug
    Veradermics is for the first time reporting positive efficacy of its oral formulation of minoxidil in female pattern hair loss, which broadens the market potential of its flagship asset. In a mid…
    Endpoints · 10d ago↗ source
  • Why Axiom hopes it’s ‘solved 2 major potholes’ that have hurt other stem cell biotechs
    When Axiom's stem cell therapy demonstrated a 0% mortality rate over two years in potentially fatal newborn neurological diseases this week, the biotech's leadership saw a broader validation for th…
    Fierce Biotech · 10d ago↗ source
  • STAT+: Medicare Advantage insurers face new bipartisan scrutiny over AI and care denials
    Blumenthal, Hawley press UnitedHealth, Humana, CVS for documents related to using AI to deny or delay care.
    STAT · 10d ago↗ source
  • STAT+: Under a new leader, the FDA’s biologics center moves to steady itself after stormy chapter
    After his predecessor's turbulent tenure, Karim Mikhail is working to restore staff morale and revisit controversial rejections.
    STAT · 10d ago↗ source
  • STAT+: A new biotech startup tries to tackle obesity, but not in the way you might expect
    A new startup is making a bold move in the world of obesity drug development: It’s not working with the GLP-1 target that has taken the world by storm.
    STAT · 10d ago↗ source
  • Opinion: Why we still don’t know what foods are the source of the cyclospora outbreak
    “You cannot thin a system, defer the tools that would speed it up, and then wonder why the public is left guessing,” writes epidemiologist Katrine Wallace.
    STAT · 10d ago↗ source
  • STAT+: Swing Therapeutics acquired by medical VR platform XR Health
    Swing Therapeutics, developer of a digital treatment for fibromyalgia, has been acquired by medical virtual reality company XR Health.
    STAT · 10d ago↗ source
  • Flood of comments on White House grantmaking overhaul is largely negative, analysis shows
    An analysis of public comments on a White House proposal to change the way federal contracts and grants are doled out shows widespread opposition
    STAT · 10d ago↗ source
  • I&I startup Attovia files to go public as biotech listings momentum builds
    The tally of biotechs waiting to list in the coming weeks has increased to three, as biologics maker Attovia Therapeutics filed for an initial public offering on Tuesday after the market closed.…
    Endpoints · 10d ago↗ source
  • Diamantas backtracks on Makary’s policies issued in journal articles
    <p>The acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official…
    raps · 10d ago↗ source
  • STAT+: FTC settles lawsuit with CVS Caremark over charges it manipulated insulin prices, impeded access
    The FTC settled a lawsuit against CVS Caremark over allegations that the company artificially inflated the price of insulin and impeded access to the diabetes treatment.
    STAT · 10d ago↗ source
  • Celcuity wins approval for breast cancer drug Revtorpyk
    A small public biotech won approval for a breast cancer drug that was designed to improve on similar treatments from Novartis and Roche. The FDA on Tuesday cleared Celcuity's Revtorpyk in combina…
    Endpoints · 10d ago↗ source
  • STAT+: Sales from controversial U.S. drug discount program rose to $100 billion last year
    Prescription drugs purchased under a controversial government discount program amounted to $100 billion in 2025, a 22.8% increase from the previous year.
    STAT · 10d ago↗ source