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1,997 stories matching this filter · ← front page

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  • European regulators approve Fractyl Health's first GLP-1 gene therapy clinical trial
    European regulators have given the green light for Fractyl Health, a biotech near Boston, to begin its first human study of a GLP-1 gene therapy. The therapy aims to provide a one-time treatment t…
    Endpoints · 4mo agoRegulatoryPositive↗ 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
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  • 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
  • Optum Rx Announces Transparent Pharmacy Model Set to Launch in 2027
    Optum Rx, a unit of UnitedHealth Group, introduced a new pharmacy benefit model that promises clear fee structures for its customers. The model is designed to give members visibility into the full…
    Endpoints · 4mo agoPositive↗ source
  • Novo Nordisk secures biotech partner for Parkinson's cell therapy as GSK signs hepatitis B drug deal in China
    Novo Nordisk has found a biotech partner to advance its early‑stage Parkinson's disease cell therapy, giving the program a new development home. GSK disclosed a commercial agreement to sell its he…
    Endpoints · 4mo agoDealNeutral↗ 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
  • 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
  • Nivolumab added to standard radiation and hormone therapy yields 90% two-year disease control in high-risk prostate cancer
    A Phase 2 trial evaluated the combination of nivolumab with standard radiation and hormone therapy in patients with high‑volume grade group 5 prostate cancer. The study reported a 2‑year freedom f…
    onclive · 4mo agoPositive readoutPositive↗ source
  • OncLive highlights key advances in ovarian, Hodgkin lymphoma, pancreatic, melanoma and myelofibrosis therapies
    The weekly "Five Under 5" roundup from OncLive curates the most notable oncology video content released during the first week of May. It spotlights recent data across a range of cancer types, offer…
    onclive · 4mo agoNeutral↗ source
  • FDA approves zenocutuzumab for previously treated NRG1-fusion cholangiocarcinoma
    The FDA has granted approval for zenocutuzumab to treat patients with previously treated, advanced cholangiocarcinoma that carries an NRG1 fusion. The decision was based on data from the eNRGy stud…
    onclive · 4mo agoApprovalPositive↗ source
  • Antibody-drug conjugates poised to move lung cancer treatment earlier, boosting response rates and targeting brain metastases
    Experts highlight that antibody‑drug conjugates are reshaping non‑small cell lung cancer therapy, moving beyond their traditional role in later‑line settings. The new agents have demonstrated high…
    onclive · 4mo agoPositive↗ source
  • Endpoints Weekly highlights biotech company models, a quirky startup story, and earnings season updates
    The latest edition of Endpoints Weekly introduces a look at emerging biotech company structures, noting how new models are reshaping the industry. It also features a light‑hearted piece about a st…
    Endpoints · 4mo agoNeutral↗ source
  • Zongertinib Shows 76% Response Rate in HER2-Mutant NSCLC, Paving Way for Accelerated FDA Approval
    Zongertinib achieved a 76% overall response rate and a median response duration of 15.2 months in treatment‑naïve patients with HER2‑mutant advanced or metastatic non‑small cell lung cancer. The da…
    onclive · 4mo agoApprovalPositive↗ source
  • Lilly adds $4.5 billion to Indiana manufacturing to boost weight-loss drug supply
    Eli Lilly & Co. announced an additional $4.5 billion investment in two of its three manufacturing sites in Lebanon, Indiana. The funding is aimed at expanding capacity for both its genetic therapie…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Capivasertib plus fulvestrant shows numerical overall-survival gain in PIK3CA/AKT1/PTEN-altered advanced breast cancer
    The CAPItello-291 phase III trial enrolled 708 patients with advanced breast cancer and randomized them 1:1 to receive capivasertib (400 mg twice daily on a 4‑on/3‑off schedule) plus fulvestrant, o…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Pimicotinib shows 76% response rate and functional benefits in TGCT phase 3 trial
    Dr. Randall discussed results from the phase 3 MANEUVER trial of the CSF-1 receptor inhibitor pimicotinib in patients with tenosynovial giant cell tumor (TGCT). The data were presented at the 2025…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Biomarker-directed therapies reshape GI cancer treatment, says expert
    In a recent OncLive On Air podcast, host Courtney Flaherty spoke with Dr. Michael J. Pishvaian about the growing role of biomarker-directed strategies in gastrointestinal oncology. Dr. Pishvaian n…
    onclive · 4mo agoNeutral↗ source
  • FDA approves Zenocutuzumab for NRG1 fusion-positive advanced cholangiocarcinoma
    The U.S. Food and Drug Administration has granted approval for zenocutuzumab-zbco, marketed as Bizengri, to treat adult patients with NRG1 fusion‑positive advanced, unresectable or metastatic chola…
    onclive · 4mo agoApprovalPositive↗ source
  • Trump reportedly plans to dismiss FDA Commissioner Marty Makary
    Multiple media outlets report that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The reports say the decision has not been finalized and could still be…
    Endpoints · 4mo agoRegulatoryNegative↗ source