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  • US-China biotech rivalry sparks calls for deeper discussion, says editor
    The editor notes that the ongoing debate over the competitive relationship between U.S. and Chinese biotechnology sectors has been unfolding over recent months. While many knowledgeable voices are…
    Endpoints · 3mo agoNegative↗ source
  • Aurora Therapeutics halts its custom CRISPR program and cuts staff after competitor Beam moves ahead
    Aurora Therapeutics, a startup developing personalized gene-editing drugs, announced it is abandoning its lead CRISPR program. The decision came just seven months after the company launched, and i…
    STAT · 3mo agoLayoffsNegative↗ source
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  • Early Alert: Intraosseous Needle Set Issue from Becton Dickinson
    BD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
    fda medwatch · 3mo agoRegulatoryNeutral↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA invites stakeholder input to shape a new Quantitative Medicine Innovation Network
    The FDA announced it is looking for feedback from a broad range of stakeholders to help design a Quantitative Medicine Innovation Network (QMIN). The proposed QMIN would be a cross-sector platform…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Amgen drops early-stage obesity drug candidate AMG-513
    Amgen announced it is discontinuing its early-stage obesity candidate AMG-513. The program was in Phase 1, but the company provided no details about the study or the reasons for the halt. A spokes…
    Endpoints · 3mo agoNegative↗ source
  • Two Michigan Cyclospora Deaths Reported as Eli Lilly Expands Special Retatrutide Access
    Two people in Michigan have died after contracting cyclospora, a parasitic infection that is rarely fatal but can be severe for those with underlying health conditions. State health officials confi…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Patient finds open-source diabetes app improves control despite lack of FDA approval
    Patient has type 1 diabetes for over 30 years and has used FDA-approved pumps and sensors that were upgraded roughly every five years. Over time his glucose control slipped despite the regulated de…
    STAT · 3mo agoPositive↗ source
  • Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
    Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging. The recall was…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Experts debate extra regulation for low-risk digital wellness devices
    Two recent papers published in JAMA have highlighted concerns about low-risk digital health technologies that consumers use. Experts say that even though these tools are considered low-risk, they…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Novo vs. Lilly: Q2's cardiometabolic grudge match
    For years, Novo Nordisk and Eli Lilly have dominated the conversation surrounding obesity medicines as the duopoly competes to lead the largest pharmaceutical category in history. While dozens of c…
    Endpoints · 3mo agoNeutral↗ source
  • New York study questions effectiveness of involuntary outpatient mental health treatment, urges more funding for voluntary services
    A new evaluation of New York's involuntary outpatient treatment program adds to a growing body of research on court‑ordered mental health care. The study examined outcomes for people with serious c…
    STAT · 3mo agoNegative↗ source
  • Physician reflects on Quebec's assisted-suicide landscape through Josée Lamère’s story
    Sai Rajagopal, a Canadian physician and researcher, writes an opinion piece that follows the life of Josée Lamère, who became one of the 7.9 percent of Quebecers who have chosen assisted suicide. H…
    STAT · 3mo agoNeutral↗ source
  • FDA expands Pluvicto label, allowing most metastatic prostate cancer patients to receive the therapy
    The U.S. Food and Drug Administration has approved an expanded label for Novartis’ radiopharmaceutical Pluvicto, permitting its use together with hormone therapy in metastatic prostate cancer. The…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Curium to acquire Lantheus in deal valued up to $8 billion
    Curium announced it will purchase all outstanding shares of Lantheus for $102.50 cash per share, with potential additional $12 per share via contingent value rights linked to sales milestones in pr…
    Fierce Biotech · 3mo agoDealNeutral↗ source
  • California Supreme Court rejects claim that Gilead must fast-track safer HIV drug
    Thousands of patients sued Gilead Sciences, alleging the company was negligent for delaying a safer HIV medicine and that they suffered kidney injury and bone loss from the older drug. The Califor…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Medicare to End Extra Payments for FDA Breakthrough Devices Starting FY2028
    Medicare announced that it will eliminate the special pathways that have let medical devices labeled as breakthrough by the FDA receive supplemental payments without showing a clear clinical advant…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Curium to acquire Lantheus in $8 billion deal, offering $102.5 per share with upside potential
    Curium announced it will purchase radiopharmaceutical company Lantheus in a transaction valued at about $8 billion. The agreement sets the purchase price at $102.5 for each Lantheus share, and inc…
    Endpoints · 3mo agoDealNeutral↗ source
  • Sandoz to Pay $478.5 Million to Settle Generic Drug Price-Fixing Claims
    Sandoz has agreed to pay $478.5 million to resolve allegations that it participated in a widespread conspiracy to inflate and manipulate the prices of generic medicines. Dozens of U.S. states and i…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Analyst warns AstraZeneca-BMS merger could spark regulatory hurdles and job cuts
    Angus Liu writes an editorial warning that talks of a merger between AstraZeneca and Bristol Myers Squibb could create more problems than benefits. He notes that the two companies have only discuss…
    Fierce Biotech · 3mo agoDealNegative↗ source
  • Analysts Question Potential AstraZeneca-Bristol Myers Megamerger
    Analysts are scrutinizing a recent report that suggests AstraZeneca could merge with Bristol Myers Squibb. The proposed megamerger has sparked a series of questions about strategic fit and executio…
    Endpoints · 3mo agoDealNeutral↗ source
  • Eli Lilly’s one-patient early access to retatrutide leaves doctors seeking answers
    Eli Lilly granted a single 79-year-old patient special access to retatrutide, an experimental obesity drug that has shown weight‑loss results comparable to bariatric surgery. Since that decision,…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Moderna awaits FDA decision on mRNA flu vaccine as biotech fund launches and pricing disputes intensify
    Moderna is awaiting the FDA's decision on its mRNA influenza vaccine, which could become the first seasonal flu shot using messenger RNA technology. Meanwhile, venture firm TCGX announced a new $4…
    STAT · 3mo agoNeutral↗ source
  • AstraZeneca shares drop 5.5% as investors react to reported merger talks with Bristol Myers Squibb
    AstraZeneca's share price slipped on Monday after Reuters reported that the company is in merger talks with Bristol Myers Squibb. The potential combination would create a drugmaker valued at rough…
    STAT · 3mo agoDealNegative↗ source
  • BioNTech appoints Guido Oelkers as new CEO, succeeding cofounder Ugur Sahin
    BioNTech announced that Guido Oelkers will become its chief executive officer, taking over from cofounder Ugur Sahin. Oelkers comes from Swedish biopharma Sobi, where he led the company, and bring…
    STAT · 3mo agoNeutral↗ source