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  • Remembering Craig Venter: The Complex Legacy Behind the Human Genome Race
    Former NIH archivist Zachary Utz reflects on the recent death of Craig Venter, a prominent figure in genomics known for challenging conventional scientific approaches. Venter’s private company Cel…
    STAT · 5mo agoNeutral↗ source
  • Durvalumab plus enfortumab vedotin improves survival outcomes in muscle-invasive bladder cancer
    A recent clinical study evaluated the perioperative use of durvalumab together with enfortumab vedotin in patients with muscle-invasive bladder cancer. The topline results indicated that the combi…
    onclive · 5mo agoPositive readoutPositive↗ source
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  • AstraZeneca reports Phase 3 trial shows Imfinzi-Padcev combo improves survival in bladder cancer
    AstraZeneca announced that its Phase 3 study of the immunotherapy Imfinzi combined with the antibody‑drug conjugate Padcev, developed with Pfizer and Astellas, extended overall survival for patient…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • BeOne secures FDA approval for lymphoma therapy
    BeOne received FDA approval for its lymphoma therapy, a notable achievement in a crowded therapeutic area. The agency’s review concluded that the treatment meets safety and efficacy standards, pla…
    STAT · 5mo agoApprovalPositive↗ source
  • Regenxbio reports key gene therapy results, moves toward FDA accelerated clearance for Duchenne
    Regenxbio said its experimental gene therapy RGX-202 met the primary endpoint in a pivotal Duchenne muscular dystrophy trial, positioning the company to file for accelerated FDA clearance. In the…
    BioPharma Dive · 5mo agoRegulatoryPositive↗ source
  • Regenxbio reports successful Duchenne gene therapy trial, clearing path to FDA filing
    Regenxbio announced that its experimental gene therapy for Duchenne muscular dystrophy met its primary endpoints in a recent clinical trial, producing sufficient levels of a truncated muscle protei…
    STAT · 5mo agoPositive readoutPositive↗ source
  • Supreme Court blocks restrictions, keeps mifepristone available through pharmacies and mail
    Supreme Court on Thursday issued an order that maintains women's ability to obtain the abortion medication mifepristone without requiring an in-person doctor visit. The decision overturns a lower-…
    STAT · 5mo agoRegulatoryPositive↗ source
  • Ibrutinib monotherapy shows ten-year durable efficacy across CLL subtypes
    Ibrutinib monotherapy has demonstrated lasting effectiveness in chronic lymphocytic leukemia across multiple disease subtypes. Data reveal that patients, including those with TP53 mutations, maint…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • Phase III trial shows tebentafusp doubles five-year survival in untreated metastatic uveal melanoma
    A Phase III study of tebentafusp in patients with previously untreated metastatic uveal melanoma reported that five-year overall survival was roughly twice that of the control group. The trial als…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Biogen advances tau-targeting Alzheimer drug to Phase 3 despite mixed Phase 2 data
    Biogen reported results from a Phase 2 trial of its tau-targeting Alzheimer’s candidate diranersen (BIIB080). The study measured tau levels in cerebrospinal fluid and brain tissue of patients with…
    STAT · 5mo agoPositive readoutPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 5mo agoApprovalPositive↗ source
  • AVB-001 Cell Therapy Demonstrates Safety and Immune Activation in Platinum-Resistant Ovarian Cancer
    AVB-001, an encapsulated interleukin-2 cell therapy, was evaluated in patients with platinum-resistant high-grade serous ovarian carcinoma. The study reported that the treatment was well tolerated.…
    onclive · 5mo agoPositive readoutPositive↗ source
  • FDA commissioner Marty Makary exits, acting head Kyle Diamantas named as podcast discusses impact and Senate health race
    The Readout Loud podcast episode focused on health politics, featuring a discussion of FDA commissioner Marty Makary's departure. Hosts examined why Makary is leaving, which of his policies might…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Encoded Therapeutics gene therapy cuts seizures 76% in Dravet syndrome children
    Encoded Therapeutics presented data at the ASGCT26 meeting showing its gene therapy achieved a 76% reduction in seizures among children with Dravet syndrome. The result was observed in three patie…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Rintatolimod added to pembrolizumab and cisplatin yields 50% response rate in recurrent ovarian cancer
    A clinical study evaluated the combination of rintatolimod, pembrolizumab and cisplatin in patients with recurrent ovarian cancer. The regimen produced an objective response rate of 50%, indicatin…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Stage IV Breast Cancer Cases Rise Over Past Decade, Dana-Farber Study Shows
    A recent analysis by Dana-Farber Cancer Institute examined breast cancer diagnoses over the past ten years. The researchers found that the number of patients diagnosed with stage IV disease has ri…
    onclive · 5mo agoNeutral↗ source
  • Degron Therapeutics raises $40M in Series A extension, total $95M, as Cabaletta releases early CAR‑T data
    Degron Therapeutics, a US‑China biotech focused on molecular‑glue degrader technology, announced an additional $40 million in Series A extension funding, bringing its total capital raised to $95 mi…
    Endpoints · 5mo agoDealNeutral↗ source
  • Biogen reports mixed results in mid‑stage trial of tau‑targeting Alzheimer’s therapy
    Biogen disclosed data from a Phase 2 study of its experimental Alzheimer’s drug that targets the tau protein. The trial showed a combination of positive and negative signals, with some measures ind…
    STAT · 5mo agoNegative readoutNeutral↗ source
  • Experts anticipate Daraxonrasib and new GI cancer therapies at ASCO 2026
    Ahead of the 2026 ASCO Annual Meeting, leading oncologists and researchers focusing on gastrointestinal cancers highlighted the topics they expect to dominate the conference. Central among the buz…
    onclive · 5mo agoNeutral↗ source
  • Triplet immunotherapy improves survival in HER2‑positive gastric cancer, suggesting broader immune activation
    New data from a study of HER2‑positive gastric cancer patients evaluated a triplet immunotherapy regimen. The analysis compared the combination against standard approaches and focused on overall su…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Zenidatamab regimens show survival benefit in HER2-positive gastric cancer, but PD-L1 test variability raises treatment questions
    The HERIZON‑GEA‑01 study reports that zenidatamab‑based treatment schedules lead to a notable improvement in overall survival for patients with HER2‑positive gastric cancer. These efficacy finding…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Biogen's anti-tau Alzheimer drug BIIB080 fails primary endpoint in Phase 2, but shows slower decline
    Biogen reported results of its Phase 2 trial of BIIB080, a tau-targeting therapy for Alzheimer’s disease. The study’s primary endpoint was not met, meaning the drug did not achieve the pre-specifi…
    Endpoints · 5mo agoNegative readoutNeutral↗ source
  • Regenxbio reports positive Duchenne gene therapy trial results, targets FDA approval by 2027
    Regenxbio announced that its gene therapy for Duchenne muscular dystrophy achieved the required endpoints in a pivotal clinical trial. The data met the study's predefined criteria, which the compa…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • CREATE Medicines raises $122 million to advance CAR-T candidates into human trials
    CREATE Medicines, formerly Myeloid Therapeutics, announced a $122 million financing round. The funding came from Newpath Partners, ARCH Venture Partners, Hatteras Venture Partners and other invest…
    STAT · 5mo agoDealPositive↗ source