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  • Gilead places partial clinical hold on two KITE-753 CAR-T trials in diffuse large B-cell lymphoma
    Gilead announced on its third-quarter earnings call that it has placed a partial clinical hold on two CAR-T trials for KITE-753 targeting diffuse large B-cell lymphoma (DLBCL). The hold affects th…
    Fierce Biotech · 14d agoRegulatoryNegative↗ source
  • Merck R&D chief says company has outpaced rivals with its sac-TMT cancer platform
    Dean Li, the head of Merck Research Laboratories, said the company believes its sac-TMT cancer program gives it a competitive edge over other firms developing next-generation oncology therapies. T…
    Endpoints · 14d agoPositive↗ source
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Nephrology764
  • UK secures £500m biopharma investment as Vertex commits over £300m to new Oxford R&D hub, while Teva plans New Jersey plant closure
    The UK government’s autumn budget has attracted about £500 million in new biopharma commitments, signalling strong support for the sector. Vertex Pharmaceuticals disclosed that it will put more th…
    Endpoints · 14d agoDealNeutral↗ source
  • Ono Pharma’s endocannabinoid drug ONO-1110 fails five Phase 2 trials, prompting broader concerns
    Ono Pharma reported that its experimental endocannabinoid modulator ONO-1110 did not achieve the primary efficacy endpoint in five separate Phase 2 clinical trials. The failures span multiple indi…
    Endpoints · 14d agoNegative readoutNegative↗ source
  • Genmab shares climb after head-and-neck cancer data as Iovance and Coherus stocks fall
    Genmab's shares moved higher after the company released data from a head‑and‑neck cancer trial, which investors interpreted as a positive signal for the drug's potential. In contrast, Iovance and…
    Endpoints · 14d agoPositive readoutNeutral↗ source
  • Big tech and startups are building personal AI agents to analyze patients’ medical records
    In a recent column the author notes that personal artificial-intelligence agents are poised to enter the healthcare arena. Large technology firms and emerging startups are creating platforms that…
    Endpoints · 14d agoNeutral↗ source
  • Anthropic outlines biopharma strategy ahead of potential record-size IPO
    Anthropic, the AI startup that recently filed paperwork for what could become the largest initial public offering in business history, used its AI Day event to detail its biopharma ambitions. The…
    Endpoints · 14d agoNeutral↗ source
  • Genetic Testing Helps Refine Kidney Disease Trial Design, Says Natera Expert
    In a sponsored episode of The Top Line, Dr. Ronen Schneider, Natera's medical director of renal genetics, explains how genotype‑defined kidney disease data can improve clinical trial design. He not…
    Fierce Biotech · 14d agoPositive↗ source
  • Eli Lilly halts phase 2 Alzheimer's trial of mevidalen after missing internal targets
    Eli Lilly announced it is removing mevidalen from its pipeline, ending a phase 2 trial in symptomatic Alzheimer's disease. The decision was disclosed during the company's third-quarter earnings up…
    Fierce Biotech · 14d agoNegative readoutNegative↗ source
  • Setara Biosciences raises $90M Series A to advance neuroscience pipeline after Jazz's $820M Actio acquisition
    Jazz Pharmaceuticals completed an $820 million purchase of Actio Biosciences in September, creating a new spinout called Setara Biosciences to house the remaining drug programs. Setara has secured…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Delays in reaching clinical proof-of-concept can dramatically increase biotech cash burn
    The article explains how the timing of achieving clinical proof‑of‑concept (POC) directly affects a biotech company's cash consumption. While a study’s cost is important, the ongoing expenses of st…
    Fierce Biotech · 14d agoNegative↗ source
  • Merck says 2027 will focus on pipeline and new product launches despite recent trial wins
    Merck's chief financial officer said the company views 2027 as another year of investment, emphasizing its expanding pipeline and upcoming product launches rather than short‑term margin growth. Th…
    Fierce Biotech · 14d agoEarningsNeutral↗ source
  • Flagship Pioneering merges three portfolio companies to boost AI drug discovery
    Flagship Pioneering, a biotech incubator based in Cambridge, Massachusetts, announced it is merging three of its portfolio companies into a single organization. The consolidation includes a compan…
    Endpoints · 14d agoDealPositive↗ source
  • BMS drops $80 million neurodegeneration program after phase-1 results
    BMS announced it will not move forward with a neurodegeneration drug it licensed from Prothena, ending a program it invested $80 million in. The drug, known as BMS-986495 (formerly PRX019), comple…
    Fierce Biotech · 14d agoNegative↗ source
  • Ascletis oral GLP-1 candidate ASC30 meets primary and secondary goals in phase 2 diabetes study
    Ascletis reported that its oral GLP-1 small‑molecule candidate ASC30 achieved both its primary and secondary endpoints in a phase 2 trial involving 100 patients with type 2 diabetes. The study sho…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • FDA approves Stada's Lucentis biosimilar; Lilly claims its triple-G candidate outperforms Ozempic in diabetes
    The U.S. Food and Drug Administration has granted approval for Stada's biosimilar version of Lucentis, expanding treatment options for eye diseases. Lilly announced that its experimental "triple‑G…
    raps · 14d agoApprovalPositive↗ source
  • EMA and African regulator issue joint guidance to accelerate Ebola vaccine trials
    The European Medicines Agency and its African counterpart have released a joint position paper aimed at facilitating Ebola vaccine research. The guidance is intended to help launch clinical trials…
    raps · 14d agoRegulatoryPositive↗ source
  • Eli Lilly leans on cash-pay model to grow obesity drug sales in US and overseas
    Eli Lilly has observed that patients in the United States are prepared to pay several hundred dollars each month for treatments targeting obesity. The company has focused on a cash-pay approach, s…
    Endpoints · 14d agoNeutral↗ source
  • Dren Bio secures $350 million to advance blood-cancer therapy toward 2027 launch
    Dren Bio, a California biotech firm, announced it has closed a financing round that raised $350 million. The funding will be directed toward developing its lead blood‑cancer drug, with the company…
    Endpoints · 14d agoDealPositive↗ source
  • HHS issues interim policy allowing compounding of six unapproved peptides under set conditions
    HHS announced an interim policy that will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug su…
    raps · 14d agoRegulatoryNeutral↗ source
  • FDA issues revised draft guidance for drug-device combination product performance
    The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…
    raps · 14d agoRegulatoryNeutral↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 14d agoNeutral↗ source
  • SLR Food Distribution recalls Wise Wife ground cinnamon over possible lead contamination
    SLR Food Distribution Inc., based in Hicksville, New York, announced a voluntary recall of its Wise Wife brand ground cinnamon. The recall was issued because the product may be contaminated with e…
    fda recalls · 13d agoRegulatoryNegative↗ source
  • Genmab's bispecific combo with Keytruda halves death risk in phase 3 head‑neck cancer trial
    Genmab announced interim results from its phase 3 LiGeR-HN1 study, showing that adding the bispecific antibody petosemtamab to Merck's Keytruda significantly improved outcomes for patients with PD-…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Lilly's retatrutide outperforms Ozempic in phase 3 trial, cutting blood sugar and weight more
    Eli Lilly tested its triple-G candidate retatrutide against Novo Nordisk's Ozempic (semaglutide) in an open-label phase 3 study involving about 1,300 adults with type 2 diabetes whose glucose was n…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source