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  • A trend that isn’t fading, ultra-processed baby foods
    An FDA advisory panel serves some peptide wins, a measles record, and more health news from Morning Rounds
    STAT · 15h ago↗ source
  • STAT+: RA Capital backs upstart rival to Ultragenyx and Ionis in rare brain disease
    Oak Hill Bio, a new company backed by RA Capital and other investors, will take on Ultragenyx and Ionis in developing an Angelman syndrome medicine.
    STAT · 16h ago↗ source
  • [Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services
    <p>This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.</p>
    BioPharma Dive
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· 16h ago
↗ source
  • [Podcast] (Season 2) The Progress Profile: Alzheimer’s Research in Focus
    <p>This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.</p>
    BioPharma Dive · 16h ago↗ source
  • AstraZeneca looks to AI to ease risk in late-stage trials, speed up filings
    AstraZeneca’s use of AI in drug design and development has not yet yielded any clinical-stage candidates, CEO Pascal Soriot said Monday, but he added it could be useful in boosting the success of l…
    Endpoints · 17h ago↗ source
  • Updated: AstraZeneca foresees blockbuster sales for Claudin 18.2 ADC, but Ultomiris flops in rare disease
    AstraZeneca said Monday that a key late-stage trial of its Claudin 18.2-targeting ADC in stomach cancer had succeeded, albeit with a caveat — but another Phase 3 trial of Ultomiris yielded subpar r…
    Endpoints · 17h ago↗ source
  • Schrödinger debuts AI agent Bunsen to use its physics software
    Three years ago, Schrödinger CEO Ramy Farid ruffled some feathers by pushing back on the AI fever of the moment. He said AI hype was at "dangerous" and "insane" levels, warning there ...
    Endpoints · 17h ago↗ source
  • Argenx to pick up autoimmune biotech Forte Biosciences for $2.2B
    Argenx will spend $2.2 billion to buy Forte Biosciences and its anti-CD122 monoclonal antibody that’s under investigation for autoimmune diseases. The Belgian-Dutch pharma said Monday it will pay…
    Endpoints · 17h ago↗ source
  • From confidence to capital: Positioning biotech for the next growth cycle
    <p>How can biotechs be investor ready? Key takeaways from BIO International and DIA China 2026.</p>
    BioPharma Dive · 19h ago↗ source
  • Opinion: How midwives like me can help fight medical misinformation
    “I have come to believe that changing a mind is rarely the point. Planting a seed is,” writes nurse-midwife Mara Evans.
    STAT · 19h ago↗ source
  • STAT+: As some medical schools embrace RFK Jr.’s nutrition push, they deftly sidestep MAHA priorities
    Even as some medical schools heed health secretary Robert F. Kennedy Jr.’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t…
    STAT · 19h ago↗ source
  • Opinion: E-bikes, e-scooters are a burgeoning pediatric public health emergency
    “Emergency departments across America report dramatic increases in serious injuries from e-bikes and e-scooters,” write CHOP’s J. Todd R. Lawrence and Madison A. Kesler.
    STAT · 19h ago↗ source
  • STAT+: Argenx to buy Forte Biosciences for $2.2B
    Argenx plans to buy Forte Biosciences for $2.2 billion, expanding its pipeline of drugs that could treat multiple autoimmune diseases.
    STAT · 20h ago↗ source
  • Denmark’s foundation‑fueled biotech boom redraws the Nordic map
    Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.
    BioSpace · 21h ago↗ source
  • Lilly, AbbVie climb aboard in vivo CAR T train—but safety remains a hurdle
    Safety will be the key determinant of in vivo CAR T therapies, according to H.C. Wainwright’s Mitchel Kapoor, who noted that convenience and efficacy won’t be enough to impress investors in this sp…
    BioSpace · 1d ago↗ source
  • Summit, Merck must navigate new regulatory terrain in China-first cancer landscape
    Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be requir…
    BioSpace · 1d ago↗ source
  • FDA has recommitted to adcomms—but to what end?
    The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings…
    BioSpace · 1d ago↗ source
  • Recon: WHO releases first interim list of medical device authorities; AstraZeneca using AI to hedge late-stage risks
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 1d ago↗ source
  • Researchers find similar drug development to reimbursement timelines for major markets
    <p>Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.</p>
    raps · 1d ago↗ source
  • EMA says it takes ultimate responsibility for protecting online meeting registration, survey information
    <p>The European Medicines Agency (EMA) has issued notices stating how it will comply with certain stakeholder information protection under the Data Protection Regulation for EU institutions, bodies…
    raps · 1d ago↗ source
  • FDA finalizes three guidances to broaden cancer clinical trial eligibility
    <p>The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trial…
    raps · 1d ago↗ source
  • Asia-Pacific Roundup: TGA adopts 23 international scientific guidelines
    <p>Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council f…
    raps · 1d ago↗ source
  • Amgen lays off around 40 employees
    Follow along as BioSpace tracks job cuts and restructuring initiatives.
    BioSpace · 1d ago↗ source
  • Anthropic’s life science plans; Novartis CEO on China deals; and more
    Welcome back to Endpoints Weekly! We’re gearing up for a busy week of earnings coverage, as Moderna, AstraZeneca, GSK, Bristol Myers Squibb and more are set to report their Q2 results. In the meant…
    Endpoints · 2d ago↗ source
  • Opinion: I led the FDA’s food safety and nutrition center. Here’s what people are missing about the cyclospora outbreak
    “Consumers should not be faced with a trade-off between nutrition and food safety,” writes Susan Mayne, former director of the FDA Center for Food Safety and Applied Nutrition.
    STAT · 3d ago↗ source