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  • Moderna and Merck aim to file personalized cancer vaccine for FDA approval after Phase 3 success
    Moderna CEO Stéphane Bancel said the company’s personalized cancer vaccine, intismeran, met its primary goals in a pivotal Phase 3 trial. The success was disclosed during an interview at the ESMO m…
    STAT · 15d agoPositive readoutPositive↗ source
  • Melanoma vaccine shows 42% risk reduction at ESMO 2026, but shares tumble on early data release
    Moderna and Merck presented Phase 3 results for their melanoma vaccine intismeran autogene at the European Society for Medical Oncology meeting. The trial reported a 42% reduction in the relative r…
    BioPharma Dive · 14d agoPositive readoutNeutral↗ source
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  • Merck/Kelun ADC sac-TMT cuts death risk by one-third in advanced endometrial cancer
    A randomized Phase 3 trial showed that the antibody‑drug conjugate sacituzumab tirumotecan (sac‑TMT) reduced the risk of death by about one‑third in patients with advanced endometrial cancer. The…
    STAT · 14d agoPositive readoutPositive↗ source
  • GSK gains another cancer drug approval and unveils promising chemo data as it prepares for lung cancer approval
    GSK received regulatory approval this week for one of its cancer medicines in an additional tumor indication, expanding the portfolio that has grown since the company re-entered oncology a decade a…
    STAT · 14d agoApprovalPositive↗ source
  • Incyte reports lasting tumor responses in pancreatic cancer patients using targeted drug plus chemotherapy
    Incyte announced at the European Society for Medical Oncology meeting that its targeted therapy, when combined with standard chemotherapy, produced durable tumor responses in a subset of pancreatic…
    STAT · 15d agoPositive readoutPositive↗ source
  • Moderna CEO Bancel optimistic after Phase 3 success of mRNA melanoma vaccine intismeran
    Moderna chief executive Stéphane Bancel said the company will move quickly to obtain FDA approval for its experimental melanoma therapy intismeran after a Phase 3 trial showed positive results. Th…
    STAT · 15d agoPositive readoutPositive↗ source
  • Bon Secours Mercy Health to Acquire Surgery Partners in $5.7 B Deal, Expanding Ambulatory Surgery Network
    Nonprofit Bon Secours Mercy Health announced it will buy Surgery Partners, a publicly traded operator of more than 200 ambulatory surgery centers, short-stay hospitals and physician practices. The…
    STAT · 14d agoDealPositive↗ source
  • Corxel to go public via $300 million SPAC merger, advancing GLP-1 pill CX11 and amylin candidate
    Corxel Pharmaceuticals announced it will become a public company by merging with the SPAC Amanat Acquisition Corp., accompanied by a $300 million private investment. The transaction will fund the…
    BioPharma Dive · 14d agoDealPositive↗ source
  • House lawmaker probes PBMs over alleged punitive audits of independent pharmacies
    House Committee Chairman James Comer sent letters to CVS Caremark, OptumRx and Express Scripts alleging that independent pharmacies faced a sudden increase in audits after publicly supporting his P…
    STAT · 14d agoRegulatoryNegative↗ source
  • Health insurance premiums surge as CMS ramps up Medicaid fraud crackdown
    Premiums for health insurance are climbing sharply, putting pressure on both large and small employers. While many firms have absorbed the cost to stay competitive, smaller businesses are beginning…
    STAT · 14d agoRegulatoryNegative↗ source
  • Patient dies after receiving Bristol Myers experimental autoimmune CAR-T therapy zola-cel
    A participant in Bristol Myers Squibb’s multiple sclerosis trial died 44 days after being infused with the experimental cell therapy known as zola-cel. The company disclosed that the patient develo…
    BioPharma Dive · 14d agoNegative readoutNegative↗ source
  • Overlooked drugs can gain value when markets evolve, says Azurity CEO
    Ron Scarboro, chief executive of Azurity Pharmaceuticals, wrote about how medicines that seemed unsuccessful can become valuable when market conditions change. He argues that the industry often co…
    BioPharma Dive · 15d agoNeutral↗ source
  • Experts unveil four-stage framework for women's heart health across the lifespan
    Experts from the American Heart Association, American Academy of Pediatrics, Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists released a new framework…
    STAT · 15d agoPositive↗ source
  • Manufacturing hurdles grow as next-gen protein therapeutics gain traction
    Cytiva's sponsored piece highlights growing interest in next-generation protein-based drugs such as antibody-drug conjugates, multispecific antibodies, fragments and synthetic peptides. These moda…
    BioPharma Dive · 15d agoNeutral↗ source
  • NIH launches vaccine injury center that will also study long-term post-infection symptoms
    NIH announced a new center dedicated to investigating vaccine injuries. The center's mandate expands to include research on persistent symptoms after infections, such as long Covid. Officials sai…
    STAT · 15d agoRegulatoryNeutral↗ source
  • HHS rolls back 14 security and privacy requirements for EHR certification
    The U.S. Department of Health and Human Services issued a final rule that removes 14 of the 60 criteria used to certify electronic health record (EHR) systems. The revisions affect security, priva…
    STAT · 14d agoRegulatoryNeutral↗ source
  • First human case of cow-associated Shamonda virus reported in France
    French health officials have confirmed that a person in France has become infected with the Shamonda virus, a pathogen that previously was known to affect cattle. The World Health Organization has…
    STAT · 15d agoNeutral↗ source
  • Patient feels exhausted despite normal labs, highlighting stress and lifestyle factors
    A family nurse practitioner recounts a visit with a 43-year-old patient who complains that she no longer has the energy she had in her twenties. The doctor notes that all of the patient’s lab resu…
    STAT · 15d agoNegative↗ source
  • Researchers warn long-term AI use may foster social isolation, call for better data access
    An opinion piece by Cornell researchers raises the possibility that extended interaction with chatbots could gradually erode social connections, urging the scientific community to investigate this…
    STAT · 15d agoNegative↗ source
  • BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study
    The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.
    BioPharma Dive · 14d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Roche lung cancer drug, a Bristol CAR-T trial death, and more
    Bristol Myers Squibb reported that one patient died after receiving its investigational CAR-T therapy in an early autoimmune trial
    STAT · 15d ago↗ source
  • Merck and Moderna’s mRNA melanoma vaccine cuts recurrence risk by 42% in Phase 3 trial
    A Phase 3 study of a personalized mRNA vaccine for melanoma, developed by Merck and Moderna, showed a substantial improvement in patient outcomes. Patients receiving the vaccine together with Merc…
    STAT · 16d agoPositive readoutPositive↗ source
  • AstraZeneca highlights broad oncology portfolio at ESMO conference
    At the European Society for Medical Oncology (ESMO) meeting in Madrid, AstraZeneca used the platform to showcase its cancer research. The company presented data on both established medicines and n…
    STAT · 15d agoPositive↗ source
  • Tonight We Ride recalls Ultimate Forza male supplement after finding undeclared sildenafil, tadalafil and dapoxetine
    Tonight We Ride, LLC of Lakeville, Minnesota announced a voluntary recall of its Ultimate Forza male supplement capsules. The recall was triggered after testing revealed the product contains undec…
    fda recalls · 16d agoCRLNegative↗ source
  • Amgen and AstraZeneca present new combo data for extensive-stage small cell lung cancer at ESMO
    Day two of the European Society for Medical Oncology meeting in Madrid saw nearly 40,000 attendees gathering for the latest cancer research updates, as reported in the STAT+ newsletter. The sessio…
    STAT · 16d agoPositive readoutNeutral↗ source