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  • Bristol Myers reports Krazati confirmatory trial fails in colorectal cancer
    Bristol Myers Squibb disclosed that the confirmatory study of its investigational drug Krazati in combination with an EGFR inhibitor did not achieve its primary efficacy endpoints in patients with…
    Endpoints · 4mo agoCRLNegative↗ source
  • Roche partners with Otsuka's Astex in $25 million deal to strengthen breast cancer pipeline
    Roche's Genentech subsidiary has signed a collaboration with Astex Pharmaceuticals, a unit of Otsuka, that includes a $25 million upfront payment. The partnership is an early‑stage effort aimed at…
    Endpoints · 4mo agoDealPositive↗ source
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Nephrology760
  • Novartis to acquire Myricx Bio for $1.1 billion to expand antibody-drug conjugate pipeline
    Novartis announced it will buy London-based Myricx Bio, agreeing to pay $1.1 billion upfront. The deal gives Novartis access to Myricx's novel payload technology - an N-myristoyltransferase inhibi…
    STAT · 4mo agoDealPositive↗ source
  • Former Surgeon General Calls for Clinician-Guided Framework to Regulate Popular Peptides
    Jerome Adams, the former U.S. surgeon general, argues that the FDA should adopt a middle‑ground strategy rather than banning peptide compounds outright. He notes the rapid growth of peptide use for…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Anthropic CEO says AI’s biotech breakthrough may still be a decade away despite current hype
    In a recent on‑stage conversation, Matthew Herper interviewed Dario Amodei, the CEO and co‑founder of Anthropic, about the role of artificial intelligence in biotechnology. The discussion took plac…
    STAT · 4mo agoNeutral↗ source
  • Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
    Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.…
    fda medwatch · 4mo agoCRLNegative↗ source
  • ACA enrollment falls sharply, with Ohio and Oklahoma each losing about a third of participants
    New federal data shows steep drops in Affordable Care Act enrollment across the United States, with Ohio and Oklahoma each losing nearly one‑third of their participants. Overall, about 2.6 million…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Ebola therapy development accelerates as multiple candidates enter early trials
    A new wave of research teams are racing to develop a therapy for Ebola, according to the latest Morning Rounds newsletter. The article notes that several candidates are now moving into early‑stage…
    STAT · 4mo agoNeutral↗ source
  • FDA CDER appoints veteran GLP-1 reviewer Lisa Yanoff as acting deputy director
    Acting FDA CDER director Michael Davis promoted Lisa Yanoff to the role of acting deputy director of the Center for Drug Evaluation and Research. Yanoff is a long‑time FDA employee with deep exper…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • GOP lawmakers urge FDA under Trump to enforce diversity in clinical trial enrollment
    Republican members of Congress have asked the Food and Drug Administration, now led by President Trump, to adopt policies that require clinical trials to enroll participants who reflect the diversi…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Salk Institute President Warns of NIH Funding Cuts While Embracing AI and Brain Research Initiatives
    Gerald Joyce, president of the Salk Institute, highlighted recent reductions in NIH funding and their impact on research institutions. He said the institute is fully committing resources to artifi…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Physicians overuse diagnostic tests, urging structural changes to curb waste and antibiotic resistance
    American medicine orders more than 14 billion diagnostic tests each year, but many are performed at the wrong time or on patients who will not benefit. The author argues that while the industry ha…
    STAT · 4mo agoNegative↗ source
  • Vidcon highlights mental-health challenges faced by social video creators
    Vidcon this year devoted a significant portion of its programming to the mental health of content creators, reflecting growing concern about the pressures of online fame. In a STATus Report interv…
    STAT · 4mo agoNeutral↗ source
  • Anthropic unveils Claude Science platform as US House panel investigates Chinese clinical trial sites
    Anthropic, an artificial‑intelligence startup, announced the launch of Claude Science, a version of its Claude model built for scientific research. The new platform offers tools to help researchers…
    Endpoints · 4mo agoNeutral↗ source
  • Cadence raises $100M Series C to advance clinical AI for autonomous medical care
    Cadence, a health tech startup, announced a $100 million Series C financing round aimed at expanding its artificial intelligence platform. The new capital will support development of AI tools that…
    Endpoints · 4mo agoDealPositive↗ source
  • Vertex's Casgevy gene therapy receives FDA approval for children with sickle cell disease and beta-thalassemia
    Vertex announced that its gene therapy Casgevy has been granted FDA approval for use in pediatric patients. The decision expands the therapy's reach beyond adult indications. Casgevy is now author…
    Endpoints · 4mo agoApprovalPositive↗ source
  • Roche's KRAS G12C inhibitor divarasib outperforms Amgen and Bristol Myers Squibb drugs in Phase 3 head-to-head trial
    Roche announced that its KRAS G12C inhibitor divarasib showed superiority over existing marketed therapies from Amgen and Bristol Myers Squibb in a Phase 3 head-to-head trial in lung cancer. The t…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • AstraZeneca signs up to $1.7 billion R&D pact with China’s CSPC, marking second deal in six months
    AstraZeneca announced a new research collaboration with Chinese partner CSPC, valued at up to $1.7 billion. The agreement follows a previous large biobucks deal signed less than six months earlier…
    Endpoints · 4mo agoDealPositive↗ source
  • FDA grants first clearance for patient-facing LLM diabetes app, marking historic step for AI in medical software
    UpDoc's diabetes management app received FDA clearance, the first for software that uses patient-facing large language models. The app is designed to help patients follow treatment plans set by th…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Roche announces drug that sets new benchmark for KRAS‑driven lung cancer
    Roche has announced a new therapy that it says establishes a new standard of care for patients with KRAS‑driven lung cancer. The announcement was featured in a STAT+ newsletter, underscoring the p…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Biotech Index Surges 30% Year-to-Date as Market Rally Accelerates
    Mid-year data show the biotech sector continuing a strong rally that began in April 2025. The XBI index, the most-watched biotech gauge, rose 19% in June and is up about 30% for the year, trading…
    STAT · 4mo agoPositive↗ source
  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Scribe Therapeutics files for Nasdaq IPO, testing market appetite for early-stage gene-editing firms
    Scribe Therapeutics announced it has filed a registration statement to list its shares on the Nasdaq, marking the company’s first step toward a public offering. The filing highlights the growing i…
    Endpoints · 4mo agoDealNeutral↗ source
  • Medicare proposes 33% cut to 340B drug payments for hospitals
    Medicare has released a proposal to cut payments to hospitals for drugs bought through the 340B discount program by more than a third. Under the plan, Medicare would reimburse hospitals at the aver…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Lawmakers ask HHS to compel Eli Lilly to resume 340B hospital discounts
    A bipartisan group of congressional lawmakers has written to HHS Secretary Robert F. Kennedy Jr., urging the department to require Eli Lilly to restore 340B drug discounts for hospitals. Lilly hal…
    STAT · 4mo agoRegulatoryNegative↗ source