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  • BioNTech's HER2-directed ADC shows modest benefit and higher lung toxicity in phase 3 trial
    BioNTech reported results of its phase 3 DYNASTY-Breast02 trial evaluating trastuzumab pamirtecan (t-pam), an HER2-directed antibody-drug conjugate, in patients with HR-positive, HER2-low metastati…
    Fierce Biotech · 14d agoNegative readoutNegative↗ source
  • Australian clinical trials attract more U.S. sponsors amid regulatory uncertainty
    CROs are reporting faster startup timelines, predictable regulation, and tax incentives as reasons for increasing interest in conducting clinical trials in Australia. State-level incentives in Que…
    BioSpace · 15d agoNeutral↗ source
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  • 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 · 15d 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 · 15d agoApprovalNeutral↗ source
  • Corxel opts for SPAC merger to take oral obesity drug public on Nasdaq
    Corxel Pharmaceuticals, an obesity-focused biotech, said it will merge with Amanat Acquisition in the first half of next year to become a publicly traded company on Nasdaq. The company’s CFO noted…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Lycia Therapeutics raises $317.5 million in upsized Nasdaq IPO as Windward Bio eyes listing
    Lycia Therapeutics completed an initial public offering on Nasdaq, selling shares that generated roughly $317.5 million after the offering was upsized. The company’s debut on the exchange marks a…
    Fierce Biotech · 15d agoDealPositive↗ 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 · 14d 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 · 14d 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 · 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 · 14d 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 · 14d 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 · 14d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 16d 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 · 16d 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 · 16d agoNeutral↗ source