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Praxis wins two phase 3 trials for essential tremor — plans NDA
Praxis Precision Medicines reported that its oral small‑molecule ulixacaltamide met primary endpoints in two phase 3 trials for essential tremor, including maintenance‑of‑effect in a...
Big licensing week: Boehringer, Roche, Hansoh and Rani ink major ADC and delivery deals
Several high‑value licensing and collaboration deals reshaped dealmaking this week. Aimedbio licensed a preclinical solid‑tumor ADC to Boehringer Ingelheim in a near‑$1 billion agreement that...
FDA names nine winners for ultra-fast review — first national priority vouchers
The FDA revealed the first nine recipients of its Commissioner’s National Priority Vouchers, selecting a mix of investigational drugs, approved-abroad products and generics to test a two-month or...
Roche’s oral SERD separates itself — pill delays progression in breast cancer
Roche presented detailed ESMO data showing its oral selective estrogen receptor degrader, giredestrant, meaningfully delayed tumor progression in previously treated ER-positive, HER2-negative...
Next‑gen ADCs push into earlier disease — ESMO highlights clinical promise
New antibody‑drug conjugates presented at ESMO are extending ADC activity into earlier-stage disease and hard-to-treat subtypes. Sponsors reported encouraging response and disease-control rates...
Intratumoral bacteria found to blunt chemotherapy and immune detection
Researchers at MD Anderson reported that Fusobacterium nucleatum and related tumor‑infiltrating bacteria can induce a reversible quiescent state in epithelial cancer cells, reducing...
Praxis erases doubts — ulixacaltamide meets endpoints in two Phase 3 trials
Praxis Precision Medicines reported its small‑molecule ulixacaltamide met primary endpoints across two Phase 3 studies in essential tremor, delivering clinically meaningful functional improvements...
Megarounds return — Pelage and Tubulis secure large financings to scale programs
Private funding surged this week as Pelage Pharmaceuticals closed a $120 million Series B to advance a hair‑follicle stem cell therapy into Phase III, and Tubulis raised $361 million in a record...
Kite and Pregene strike big in vivo CAR‑T collaboration — billions on the table
Kite Pharma and Chinese biotech Pregene agreed to a high‑value collaboration focused on in vivo CAR‑T therapies, with headline potential in the low‑to‑mid‑$1‑billion range and substantial upfronts...
Ultra‑rapid WGS smashes turnaround record; digital twins aim to model cancer trajectories
Broad Clinical Labs, with Roche’s early‑access SBX platform, reported end‑to‑end sequencing and analysis of human genomes in under four hours, setting a new clinical speed benchmark and...
Big biopharma deals reshape delivery and ADC landscapes — Roche, Rani, Chugai move
Roche paid an $80 million upfront to capture global rights to Hansoh Pharma’s early colorectal ADC candidate, while Rani Therapeutics signed a deal with Chugai worth up to $1.08 billion to apply...
EMA splits on Sanofi: Wayrilz recommended, Rezurock rejected
The European Medicines Agency’s CHMP delivered mixed decisions for Sanofi this month: it recommended approval for Wayrilz (rilzabrutinib) in immune thrombocytopenia but issued a negative opinion...
Grail’s Galleri... PATHFINDER2 shows stronger accuracy as FDA filing nears
New data from Grail’s large PATHFINDER 2 study show improved performance for the company’s Galleri multi-cancer early detection test. Investigators followed nearly 36,000 adults over age 50 and...
FDA names nine for new priority review pilot — companies could see 1–2 month decisions
The U.S. Food and Drug Administration selected the first nine recipients of its Commissioner’s National Priority Voucher pilot program, a move creating a path for dramatically shortened review...
Praxis erases doubts – two Phase 3 wins open path to NDA
Praxis Precision Medicines reported that ulixacaltamide met primary endpoints in two pivotal Phase 3 trials for essential tremor, delivering both symptomatic improvement and maintenance of effect...
Kite, Pregene ink in vivo CAR‑T pact: $120M now, up to $1.64B on the table
Gilead’s Kite Pharma struck a strategic alliance with China’s Pregene Biopharma to develop next‑generation in vivo CAR‑T therapies, paying $120 million up front and creating a potential deal value...
Sophia Genetics launches Digital Twins for cancer research — RUO today, clinical hopes later
Sophia Genetics introduced Sophia DDM Digital Twins, an AI‑powered module within its Sophia DDM cloud platform that builds computational replicas of individual patients using multimodal clinical,...
Broad and Roche beat the clock: sub‑4‑hour whole‑genome sequencing workflow
Broad Clinical Labs, in collaboration with Roche and Boston Children’s Hospital, reported an ultra‑rapid whole‑genome sequencing protocol that reduces sample‑to‑variant turnaround to under four...
Tumor‑resident Fusobacterium drives cancer cell quiescence and chemo resistance
Researchers at MD Anderson reported that tumor‑infiltrating Fusobacterium nucleatum can disrupt epithelial cell interactions, induce a reversible quiescent state in cancer cells and blunt...
Tubulis banks $361M to accelerate next‑gen ADC pipeline
German antibody‑drug conjugate specialist Tubulis closed a $361 million Series C to advance its clinical ADC programs and expand manufacturing and R&D capabilities. The financing positions the...