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  • Biogen's anti-tau Alzheimer's drug misses Phase 2 goal, but claims signs of efficacy
    Here we go again? Biogen reported heavily anticipated Alzheimer’s data, saying its tau-targeting drug BIIB080 missed its primary endpoint in a Phase 2 study but slowed patients’ clinical decline at…
    Endpoints · 2mo ago↗ source
  • STAT+: Biogen’s tau-targeting Alzheimer’s drug posts mixed results in mid-stage study
    Biogen is moving its tau-targeting Alzheimer's drug into Phase 3 studies, despite mixed data from a Phase 2 trial.
    STAT · 2mo ago↗ source
  • Regenxbio hits Duchenne gene therapy milestone, eyes 2027 FDA approval
    Regenxbio said Thursday that its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, and it’s aiming for FDA approval in 2027. The biotech hopes to be the second company to com…
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Endpoints · 2mo ago
↗ source
  • STAT+: CREATE Medicines, a biotech company developing CAR-T therapies, raises $122 million
    CREATE Medicines has a new name, an expanded pipeline, and now fresh funding to propel the company’s first CAR-T candidates through human trials.
    STAT · 2mo ago↗ source
  • STAT+: Regenxbio says Duchenne gene therapy succeeded in clinical trial, paving way for FDA submission
    Regenxbio said its experimental gene therapy for Duchenne muscular dystrophy succeeded in a trial, paving the way for a submission to the FDA.
    STAT · 2mo ago↗ source
  • BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta
    BeOne Medicines has clinched an accelerated approval for its drug sonrotoclax in mantle cell lymphoma (MCL), marking the start of its bid to challenge AbbVie and Roche's Venclexta across a range of…
    Endpoints · 2mo ago↗ source
  • STAT+: ‘No drama’ Diamantas should serve biotech well as acting FDA chief
    Kyle Diamantas, the acting commissioner of the FDA, is expected to be a drama-free, stabilizing caretaker at the top of the agency.
    STAT · 2mo ago↗ source
  • STAT+: Treatment for alcohol addiction is undergoing a seismic shift. Many say it’s overdue
    The surging popularity of alternatives to Alcoholics Anonymous represents a seismic shift in the alcohol treatment landscape. Many say it's overdue.
    STAT · 2mo ago↗ source
  • Opinion: Using AI in addiction medicine could be particularly risky
    "AI can make great strides in medical decision support, but unfiltered interaction between agent and patient is dangerous," writes Steve D. Klein.
    STAT · 2mo ago↗ source
  • Evolving Oral SERD Research Seeks to Redefine Treatment Strategies in Hormone Receptor+ Breast Cancer
    Breast cancer experts discuss the nuances of ESR1 mutations and oral SERD use in hormone receptor–positive breast cancer.
    onclive · 2mo ago↗ source
  • Immunotherapy Advances in Upfront SCAC Expose Need for Better Second-Line Strategies
    Aparna R. Parikh, MD, emphasizes the feasibility of immunotherapy trials in SCAC and the need for better treatment options in the second line and beyond.
    onclive · 2mo ago↗ source
  • Hantavirus risk remains low, CDC says, citing its ‘playbook’ response
    Despite rising concern about the hantavirus outbreak on a cruise ship, two CDC doctors say the risk to the public remains low.
    STAT · 2mo ago↗ source
  • Dr Loghavi on the Significance of Updated WHO Diagnostic Criteria for AML in Clinical Practice
    Sanam Loghavi, MD, discusses updated WHO diagnostic criteria for acute myeloid leukemia and its significance for diagnoses and treatment selection.
    onclive · 2mo ago↗ source
  • Officials say $1.3 billion in Medicaid money to California will be deferred over suspicions of fraud
    Vice President JD Vance announced a $1.3 billion deferral in Medicaid reimbursements to California, as part of an initiative to root out fraud in federal health programs.
    STAT · 2mo ago↗ source
  • Opinion: The hantavirus is a wake-up call. Will the Trump administration answer it?
    Arriving in the isolation ward of a biocontainment hospital is an unsettling, scary experience. In 2014, I spent 19 days in one while being treated for Ebola, watching the news…
    STAT · 2mo ago↗ source
  • #ASGCT26: After an apparent cure, a gene editing company struggles to repeat the magic
    BOSTON — Early last year, startup iECURE’s experimental gene therapy seemingly cured a baby of a life-threatening genetic disease. But new results testing the same therapy in a larger number of bab…
    Endpoints · 2mo ago↗ source
  • FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML
    The FDA has approved oral decitabine/cedazuridine plus venetoclax for newly diagnosed AML unfit for intensive chemo, based on phase 2 ASCERTAIN-V data.
    onclive · 2mo ago↗ source
  • FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma
    The FDA granted accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma after at least 2 lines of systemic therapy.
    onclive · 2mo ago↗ source
  • Takeda to target 4,500 jobs as incoming CEO continues restructuring
    Takeda will cut roughly 9% of its workforce over the next fiscal year as the next CEO puts her stamp on a yearslong restructuring. About 4,500 roles will be affected, the company said Wednesday in ...
    Endpoints · 2mo ago↗ source
  • Dr Dinardo on the FDA Approval of Decitabine/Cedazuridine Plus Venetoclax in AML
    Courtney D. DiNardo, MD, MSCE, discusses the FDA approval of decitabine/cedazuridine plus venetoclax in acute myeloid leukemia.
    onclive · 2mo ago↗ source
  • Opinion: Hospitals are silencing doctors online, and it’s fueling the health misinformation crisis
    Hospitals and health systems need to loosen the reins and let physicians combat social media misinformation, writes Adam Goodcoff.
    STAT · 2mo ago↗ source
  • Tirabrutinib and CAR T-Cell Therapy Represent Potential Paradigm Shifts in R/R PCNSL
    Ashley Sumrall, MD, FACP, FASCO, discusses emerging data for tirabrutinib and the evolving role of CAR T-cell therapy in primary central nervous system lymphoma.
    onclive · 2mo ago↗ source
  • Valneva to cut up to 15% of jobs as reduced travel hits vaccine demand
    French vaccine maker Valneva is laying off 10% to 15% of its workforce and reducing revenue projections due to "an emerging adverse trend in travel vaccine uptake across key markets." The drugmaker
    Endpoints · 2mo ago↗ source
  • Future Directions in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono conclude the discussion by reflecting on the evolving future of radiopharmaceutical therapies in metastatic castration-resistant prostate cancer (mCRPC) and…
    onclive · 2mo ago↗ source
  • Personalized Treatment Decision-Making in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss the increasing complexity of personalized treatment decision-making in metastatic castration-resistant prostate cancer (mCRPC) as radiopharmaceutical…
    onclive · 2mo ago↗ source