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  • Colombian court upholds compulsory license for HIV drug, affirming legal framework
    The Court of Justice of the Andean Community ruled that Colombia's issuance of a compulsory license for an HIV medicine two years ago was lawful. The tribunal said the government had a valid publi…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Zanubrutinib shows longer overall survival than ibrutinib in real-world relapsed/refractory mantle cell lymphoma
    A retrospective real‑world analysis examined outcomes of covalent BTK inhibitors in patients with relapsed or refractory mantle cell lymphoma who received treatment in the second or third line. Th…
    onclive · 4mo agoPositive readoutPositive↗ source
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  • Medicare falls short on projected Alzheimer’s drug costs as fewer seniors use Leqembi
    Bob Herman reports that Medicare's earlier estimate that the new Alzheimer's therapy Leqembi would cost the program $3.5 billion in 2025 has proved far too high. The agency's actuaries based the fo…
    STAT · 4mo agoRegulatoryNegative↗ source
  • FDA policy lets some flavored vapes stay on shelves without full approval, raising expert concerns
    The Food and Drug Administration announced a new guidance that allows certain flavored e-cigarettes and nicotine pouches to remain on the market even though they have not received full authorizatio…
    STAT · 4mo agoRegulatoryNegative↗ source
  • GSK partners with Sino Biopharma to expand access to hepatitis B drug bepirovirsen in China
    GSK announced a marketing agreement with Sino Biopharmaceutical to distribute its experimental hepatitis B therapy bepirovirsen in China. Sino's subsidiary will purchase a supply of the drug and u…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • INBRX-106 plus pembrolizumab shows higher response rate than pembrolizumab alone in first-line PD-L1-positive head-and-neck cancer
    The HexAgon-HN trial evaluated the OX40 agonist INBRX-106 combined with pembrolizumab in patients with treatment-naive, PD-L1‑positive metastatic or unresectable head‑and‑neck squamous cell carcino…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Astellas therapy brings new hope to rare disease patients amid broader biotech challenges
    A new Astellas treatment is being highlighted as a source of optimism for a community affected by a rare disease, after a period of setbacks in the program. The article also notes a revived gene t…
    STAT · 4mo agoPositive↗ source
  • Biotech layoffs slow as companies like BioNTech cut nearly 1,900 jobs amid market pressures
    The biotech sector has seen more than 40 layoff announcements through the end of April 2026, a decline from the over 50 rounds reported in the final months of 2025. Analysts had expected the pace t…
    BioPharma Dive · 4mo agoLayoffsNegative↗ source
  • Medicare uptake of newly approved Alzheimer’s drugs Leqembi and Kisunla falls short of expectations
    Medicare is seeing much lower use of the two Alzheimer’s treatments that received FDA approval earlier this year. The drugs, Leqembi and Kisunla, were expected to generate notable spending for Med…
    STAT · 4mo agoRegulatoryNegative↗ source
  • ctDNA testing shows promise for renal cell carcinoma and germ cell tumors despite current limitations
    Experts discussed how circulating tumor DNA (ctDNA) monitoring, long used in bladder cancer, is being explored for renal cell carcinoma (RCC) and germ cell tumors. In RCC, low tumor shedding has l…
    onclive · 4mo agoNeutral↗ source
  • ctDNA monitoring guides immunotherapy decisions in metastatic urothelial cancer
    Experts discussed how circulating tumor DNA (ctDNA) testing is being used to follow patients with metastatic urothelial carcinoma and to help shape immunotherapy choices. They noted that a rapid d…
    onclive · 4mo agoPositive↗ source
  • Specialized logistics critical for delivering next-generation cell and gene therapies
    The article explains that personalized medicines such as cell and gene therapies are transforming treatment for rare diseases and cancers. Unlike conventional drugs, these therapies are often made…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Biopharma capacity crunch shifts focus to ready-now manufacturing hubs like Middlesex County, NJ
    Demand for biopharma manufacturing, especially cell and gene therapies, is growing faster than the ability to build new GMP-ready facilities, which can take years to complete. To keep pace, compan…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Experts call for licensing framework as Utah pauses AI chatbot prescription program
    Alon Bergman, an assistant professor of medical ethics at the University of Pennsylvania, argues that AI-driven medical tools need a licensing system. He points to Utah’s recent pilot with the AI c…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Medicare cuts projected spending on new Alzheimer’s drugs as uptake remains low
    Medicare is spending far less on the recently approved Alzheimer’s treatments Leqembi and Kisunla than officials had anticipated. The Centers for Medicare and Medicaid Services said the agency does…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Experts highlight growing role of treatment intensification for metastatic castration-sensitive prostate cancer
    During an OncLive Peer Exchange, prostate-cancer specialists examined how treatment intensification is reshaping management of metastatic castration-sensitive prostate cancer. They noted that andr…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss when to start therapy for pediatric low‑grade glioma, weighing chemo, MEK inhibitors and family factors
    In a recent discussion, pediatric neuro‑oncologists examined how to decide when to begin treatment for low‑grade glioma in children. They highlighted the need to balance chemotherapy and MEK inhibi…
    onclive · 4mo agoNeutral↗ source
  • Dr Randall explains rationale for CSF-1R inhibitor pimicotinib in tenosynovial giant cell tumor trial
    Dr Randall, a professor at UC Davis Comprehensive Cancer Center, discussed the clinical reasoning behind testing the selective CSF-1R inhibitor pimicotinib (ABSK021) for tenosynovial giant cell tum…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss how real-world patient factors shape first-line renal cell carcinoma treatment choices
    Dr. Elizabeth Plimack and Dr. Yasser Ged appeared in a recent segment to talk about first-line treatment selection for renal cell carcinoma. They explained that beyond clinical trial results, real…
    onclive · 4mo agoNeutral↗ source
  • Clinicians balance symptoms, MRI changes and family goals when deciding treatment for pediatric low-grade glioma, beyond size criteria
    In a recent discussion, pediatric neuro‑oncology experts examined how they apply the RAPNO criteria to assess low‑grade gliomas in children. They highlighted that treatment decisions often go beyon…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss practical treatment selection for renal cell carcinoma across risk groups
    A recent educational segment featured Dr. Elizabeth Plimack together with Dr. Sundhar Ramalingam and Dr. Yasser Ged discussing treatment choices for renal cell carcinoma. The conversation centered…
    onclive · 4mo agoNeutral↗ source
  • MimiVax and Roswell Park start Phase 2 trial of SurVaxM with temozolomide for metastatic neuroendocrine tumors
    MimiVax Inc. and Roswell Park Comprehensive Cancer Center announced the launch of a randomized Phase 2 study evaluating SurVaxM in combination with temozolomide for patients with progressing metast…
    onclive · 4mo agoCRLNeutral↗ source
  • Providers and insurers vie to influence upcoming No Surprises Act arbitration rule
    The federal government is preparing to release a final rule that will reshape the arbitration process under the No Surprises Act. Health care providers and insurers are both scrambling to have thei…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Real-World Data Highlight Survival Benefit of Rituximab Maintenance After Frontline BR in MCL
    Rituximab following first-line bendamustine demonstrated significant OS and EFS real-world benefits in mantle cell lymphoma.
    onclive · 4mo agoNeutral↗ source
  • President Trump says government may consider approving certain forms of kratom-derived 7-OH
    President Trump suggested the federal government could move to approve some forms of 7-OH, an opioid derived from the kratom plant. 7-OH, short for 7-hydroxymitragynine, occurs naturally in kratom…
    STAT · 4mo agoRegulatoryNeutral↗ source