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  • 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
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  • 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 · 15d 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 · 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
  • ESMO 2026: Merck’s Kelun-partnered ADC cuts death risk by over 30% in endometrial cancer
    Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first…
    BioSpace · 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
  • Incyte reports strong early results for KRAS G12D inhibitor in pancreatic cancer, rivals RevMed
    Incyte presented phase 1 data at the European Society for Medical Oncology congress in Madrid, highlighting its KRAS G12D inhibitor INCB161734 combined with chemotherapy for pancreatic ductal adeno…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • J&J touts promising RIPTAC data with 59% PSA reductions in prostate cancer trial
    At the European Society for Medical Oncology (ESMO) 2026 meeting in Madrid, Johnson & Johnson presented early clinical data from its RIPTAC platform, which the company acquired through a $3 billion…
    Fierce Biotech · 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
  • ESMO: BMS’ Massacesi hails ‘very promising’ data for BioNTech-partnered PD-L1xVEGF-A drug
    Bristol Myers Squibb Chief Medical Officer Cristian Massacesi, M.D., has told Fierce that the latest data for its BioNTech-partnered PD-L1xVEGF-A drug are “very promising,” as phase 3 ambitions ram…
    Fierce Biotech · 16d agoNeutral↗ source
  • Roche reports superior survival for KRAS G12C inhibitor divarasib in phase 3 trial
    Roche presented detailed results from its phase 3 Krascendo 1 trial of the KRAS G12C inhibitor divarasib, comparing it with Amgen’s Lumakras and Bristol Myers Squibb’s Krazati. The open‑label stud…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Merck and Moderna disclose phase 3 cancer vaccine data early after leak, showing improved recurrence-free survival with Keytruda
    Merck & Co. and Moderna were forced to release their phase 3 trial results for the intismeran autogene cancer vaccine two days ahead of schedule after an unexpected leak of the data ahead of the ES…
    Fierce Biotech · 17d agoPositive readoutNeutral↗ source
  • AstraZeneca says phase 3 ADC shows strong overall survival despite missing progression-free survival endpoint
    AstraZeneca executives emphasized that the detailed data from their phase 3 study of the next‑generation antibody‑drug conjugate are robust enough to be presented to regulators, even though the tri…
    Fierce Biotech · 17d agoPositive readoutNeutral↗ source
  • Genmab reports phase 3 success for Elahere competitor and previews Merus buyout data
    Genmab disclosed at the European Society for Medical Oncology meeting that its experimental therapy, positioned as a rival to Elahere, achieved a positive outcome in a phase 3 trial. The result si…
    Fierce Biotech · 17d agoPositive readoutPositive↗ 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
  • Christina Applegate’s misdiagnosis highlights ongoing challenges in multiple sclerosis diagnosis
    Actor Christina Applegate, who was diagnosed with multiple sclerosis five years ago, recently disclosed that she was initially misdiagnosed. Her public story puts a human face on the difficulty doc…
    STAT · 17d agoNeutral↗ source
  • Opinion reflects on Theranos failures and the impracticality of its testing model
    The piece appears in STAT’s First Opinion section and is authored by Torie Bosch, who invites readers to submit letters of response to opinion essays. Bosch highlights a letter from Tyler Shultz,…
    STAT · 17d agoNeutral↗ source
  • Patient dies in Bristol Myers Squibb autoimmune CAR-T trial, raising safety concerns
    Bristol Myers Squibb reported that a participant in its Phase 1 CAR-T study for multiple sclerosis died. The trial was testing an investigational CAR-T therapy aimed at autoimmune disease. The pat…
    STAT · 17d agoNegative readoutNegative↗ source
  • EQT to acquire Qiagen in €10.8 billion deal
    EQT, a private‑equity firm, announced it will purchase Dutch molecular diagnostics company Qiagen in a transaction valued at €10.8 billion, including €1.1 billion of net debt. The deal follows a f…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Roche warns Germany faces last chance to regain pharma investment confidence
    Roche has said that recent German healthcare reforms threaten the country's attractiveness for pharmaceutical investment. The company paused its own German investment plans after the reforms were a…
    BioSpace · 18d agoRegulatoryNegative↗ source
  • Marengo's bispecific antibody invikafusp alfa shows tumor shrinkage in 8 cancer types in Phase 2
    Marengo Therapeutics presented Phase 2 data for its bispecific antibody invikafusp alfa at the European Society for Medical Oncology meeting in Madrid. The study, part of the Start-001 first‑in‑hum…
    BioSpace · 18d agoPositive readoutPositive↗ source
  • Roche's Genentech reports 43% reduction in kidney damage marker in phase 3 IgA nephropathy trial
    Roche Genentech disclosed detailed results from its phase 3 IMAgINATION trial of the antisense oligonucleotide sefaxersen in patients with IgA nephropathy. The trial showed a 43.1% greater reducti…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
  • Takeda’s ADC arcotatug tavatecan shows survival benefit in phase 3 gastric cancer trial
    Takeda, together with Innovent Biologics, presented results from a late‑stage study of its next‑generation claudin‑18.2 antibody‑drug conjugate, arcotatug tavatecan (also known as IBI343 or TAK‑921…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source