Top News
Revolution Medicines' Rasonque (daraxonrasib) gains FDA approval for metastatic pancreatic cancer with 60% mortality reduction vs. chemotherapyPan-RAS inhibitor approved August 2026; represents first targeted therapy option for KRAS-driven PDAC meeting survival endpoint.
FDA approves Egetis' Emcitate (tiratricol) for MCT8 deficiency, an ultrarare X-linked neurometabolic disorderFirst and only approved oral treatment for the SLC16A2 mutation-driven condition affecting patients globally.
Novo Nordisk licenses Hengrui's dual GLP-1R/GIPR agonist HRS-1596 with once-weekly oral potentialAgreement underscores Novo's strategy to diversify GLP-1 portfolio beyond semaglutide with novel dosing advantages.
Beam Therapeutics sues YolTech Therapeutics and Serapha Bio, alleging former scientist stole base-editing trade secretsFormer Beam scientist allegedly co-founded YolTech to commercialize stolen IP; Serapha licensed the disputed therapy from YolTech.
More: BioPharma Dive
Novo Nordisk pays up to $2.6B to Hengrui for once-weekly GLP-1/GIP dual agonist obesity pill to challenge Lilly's oral dominanceDeal values HRS-1596 at potential $2.6B and includes $300M upfront payment as Novo addresses investor concerns over pipeline.
More: BioWorld, Pharmaceutical Technology, FT — Pharmaceuticals
PhRMA names former House Majority Leader Eric Cantor as new CEO amid industry regulatory headwindsCantor brings Washington political expertise to trade group as pharma faces pricing, patent, and access pressures.
UniQure's Huntington's gene therapy shows sustained benefit at four-year mark, though efficacy waned versus prior year readoutFour-year durability data on ifezuntirgene inilparvovec fuels debate over accelerated approval pathway viability; stock tumbles on magnitude concerns.
More: BioWorld, BioWorld, BioPharma Dive
FDA clears Currus Biologics' CUR-001, mesothelin-targeting cell therapy, for Phase I solid tumor basket trialFirst-in-human dosing expected early 2027; addresses underexplored mesothelin indication in solid tumors.
AstraZeneca invests $2B in Summit Therapeutics to combine PD-1/VEGF bispecific ivonescimab with its ADC portfolioEquity investment secures AstraZeneca seat at table for multi-tumor combination studies without ownership stake in Summit.
Scarlet Therapeutics secures up to $14M DARPA contract to develop engineered red blood cells for therapeutic deliveryAward funds multidisciplinary consortium effort to advance smart RBC platform with potential military and civilian medical applications.
CSPC gains NMPA approval to advance mRNA cancer vaccine SYS-6077 into clinical trials in ChinaProgram targets advanced malignant tumors; reflects growing mRNA oncology portfolio expansion in Asia.
Italian biotech Aptadir Therapeutics raises €40M seed to advance RNA inhibitors that reverse DNA hypermethylation-driven gene silencingNovel mechanism targets intractable genetic conditions including fragile X syndrome and myelodysplastic syndrome.
More: BioWorld
Iregene's iPSC-derived cell therapy Nouvsight-001 clears IND in US and China for retinitis pigmentosaFirst-in-human dosing expected to begin in 2027 across both regulatory jurisdictions.
AstraZeneca, Merck strike deals with Chinese biotech firms as global dealmaking in sector accelerates despite US regulatory scrutinyAkeso shares surge on AZ cancer-drug partnership; Merck also enters Chinese biotech market amid easing BIOSECURE concerns.
Tolerance Bio acquires Tanabe's anti-IL-33 antibody TLB-33 for $560M to expand thymus-focused pipelineSecond major licensing deal in six weeks for the clinical-stage immunology platform company; MT-2990 targets inflammatory conditions.
- Pharming CEO Fabrice Chouraqui steps down amid strategic disagreement with board
Departure signals potential shift in direction for the rare-disease focused biopharmaceutical company.
More: Pharmaceutical Executive
Ai3Bio, formed from two biotech mergers, targets T helper cells rather than B cells for autoimmune 'immune reset'The approach differs from competitors like GSK and Roche that pursue B-cell depletion strategies in autoimmunity.
- U.S. administration issues guidance outlining exemptions framework for proposed 100% tariffs
Pharmaceutical and biotech companies await clarity on which products, suppliers, or trade categories may qualify for relief from threatened across-the-board duties.
Durham University spinout Magnitude Biosciences raises £1.3M to commercialize VivoScan in vivo screening platformCRO plans to accelerate deployment of proprietary high-throughput screening technology for drug discovery workflows.
Merck pays $2.13B to SciBrunch for KRAS(ON) inhibitor as RAS-targeted oncology competition heats upBet follows Revolution's pancreatic cancer approval with OS-doubling benefit from RAS-targeting approach.
More: Pharmaceutical Executive
Merck licenses preclinical oral KRAS G12D inhibitor SPR-2015 from China's Scibrunch for $2.13B$400M upfront; deal covers exclusive global rights to the candidate.
More: BioWorld, Pharmaceutical Executive, BioWorld
Merck discontinues Recarbio antibiotic amid superbug resistance concerns despite clinical importanceRecarbio was one of few treatment options for multidrug-resistant gram-negative bacterial infections.
Kodiak's Phase 3 data for tarcocimab and tabir show potential to challenge Regeneron's Eylea in wet AMDStock surged on positive results for two bispecific anti-VEGF/anti-IL-6 candidates in wet age-related macular degeneration.
Sofinnova Partners closes €82M fourth early-stage medtech fund at final closeSofinnova MD Start IV was oversubscribed and will target ventures from inception through key clinical milestones.
Adicet's off-the-shelf gamma-delta CAR-T therapy outperforms personalized benchmarks in lupus trialAllogeneic cell therapy approach could simplify manufacturing and access versus autologous CAR-T competitors if efficacy holds in late-stage trials.