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  • Artiva to quit autoimmune cell therapy work, cut staff after patient deaths
    The disclosure makes Artiva the third company to recently report fatal events in an autoimmune cell therapy trial, following announcements from Novartis and Bristol Myers Squibb.
    BioPharma Dive · 16d ago↗ source
  • Roche's KRAS inhibitor divarasib shows strong results in second-line lung cancer trial at ESMO
    Roche presented data from a trial of its KRAS G12C inhibitor divarasib at the European Society for Medical Oncology meeting. The study evaluated divarasib in patients with advanced non-small cell…
    STAT · 16d agoPositive readoutPositive↗ source
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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 · 17d 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 · 17d agoPositive readoutNeutral↗ source
  • 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 16d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d agoPositive↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 17d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 17d agoApprovalNeutral↗ 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 · 17d 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 · 17d 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 · 16d 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 · 17d agoNeutral↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 17d agoRegulatoryNeutral↗ 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 · 17d 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 · 17d 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 · 17d ago↗ source