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Broad, Roche achieve sub‑4‑hour clinical WGS: record turnaround reported
Broad Clinical Labs, in collaboration with Roche and Boston Children’s Hospital, reported an ultra‑rapid whole‑genome sequencing workflow that produced variant call files in a mean of 4 hours 4...
Digital twins and AI genomics platforms accelerate target discovery and modeling
Sophia Genetics launched Sophia DDM Digital Twins, a module within its cloud Sophia DDM environment that creates computational replicas of individual cancer patients using multimodal clinical,...
FDA names first national-priority picks: review in weeks not months
The U.S. Food and Drug Administration selected the first nine recipients of its Commissioner’s National Priority Voucher (CNPV) pilot, designating investigational products that can receive an...
Roche’s oral SERD shows broad activity – detailed ESMO readout
Roche released detailed phase 3 data showing its oral selective estrogen receptor degrader, giredestrant, improved progression-free survival across patients with ER-positive, HER2-negative breast...
Celcuity posts Phase 3 win: FDA filing planned by year-end
Celcuity disclosed subgroup efficacy from its Phase 3 breast cancer program and said it plans to complete a new drug application by year-end after presenting positive data at ESMO. The biotech...
Grail’s Galleri accuracy improves... PATHFINDER data bolster FDA case
Grail reported updated PATHFINDER study results showing improved positive predictive value for its multi-cancer blood test Galleri, reinforcing claims of better accuracy as the company nears an...
Tumor microbes blunt chemo: MD Anderson maps bacterium-driven resistance
Researchers at MD Anderson reported that tumor-infiltrating Fusobacterium nucleatum can induce a reversible quiescent state in cancer epithelial cells, reducing immune detection and driving...
Gilead’s Kite inks in vivo CAR-T pact with Pregene: up to $1.64B
Kite Pharma, Gilead’s cell-therapy unit, struck a headline licensing and collaboration agreement with China’s Pregene that could reach roughly $1.64 billion, including upfront and milestones, to...
Praxis posts twin Phase 3 wins – tremor drug heads to NDA
Praxis Precision Medicines reported positive results from two Phase 3 studies of ulixacaltamide in essential tremor, meeting primary endpoints and supporting a planned new drug application in...
ADC financing surge: Tubulis lands $361M and Adcytherix raises $122M
Investor interest in antibody‑drug conjugates accelerated this week as Tubulis closed a $361 million Series C to advance its clinical ADC pipeline, and Adcytherix announced a €105 million (US$122...
Licensing wave: Roche buys Hansoh ADC rights; Rani inks $1.08B Chugai pact
Big pharma alliance activity intensified as Roche paid $80 million upfront to license Hansoh Pharma’s early-stage colorectal cancer ADC and Rani Therapeutics signed a development and...
Broad and Roche cut genome-to-result time to under four hours
Researchers at Broad Clinical Labs, in collaboration with Roche and Boston Children’s Hospital, demonstrated an ultra‑rapid whole‑genome sequencing workflow using Roche’s Sequencing-by-Expansion...
FDA pilot vouchers: nine winners named — review window slashed to weeks
The FDA announced the first nine recipients of its Commissioner’s National Priority Voucher (CNPV) pilot program, offering a pathway to regulatory decisions in one to two months. The picks include...
Roche’s oral SERD proves efficacy — data land at ESMO
Roche reported detailed phase 3 data showing its oral selective estrogen receptor degrader (SERD) giredestrant improved progression-free survival versus standard-of-care endocrine therapy in...
Next-gen ADCs push into earlier disease — promising ESMO and phase 1 signals
Antibody–drug conjugates are moving earlier in oncology as new data show activity in early-stage and previously untreatable settings. Presentations at ESMO highlighted next-generation ADCs...
Grail’s Galleri shows higher predictive value as FDA filing approaches
New, large‑cohort data from the PATHFINDER program show improvements in Galleri’s positive predictive value and sensitivity when participants were followed longitudinally, strengthening Grail’s...
Tumor‑resident bacteria linked to chemo resistance — MD Anderson maps mechanism
Researchers at The University of Texas MD Anderson Cancer Center revealed a microbe‑driven mechanism by which Fusobacterium nucleatum induces reversible quiescence in tumor epithelial cells,...
Broad and Roche set new speed record for clinical WGS — sub‑4‑hour turnaround
Broad Clinical Labs and Roche reported an ultra‑rapid whole‑genome sequencing workflow using Roche’s Sequencing‑by‑Expansion (SBX) platform that can deliver variant calling files in under four...
Plasmidsaurus launches ultrafast RNA‑seq service for quick gene‑expression readouts
Plasmidsaurus announced a rapid RNA‑seq service for Illumina short‑read workflows that promises three‑day turnaround from crude cell preps to analyzed expression data and an easy,...
Lonza clears Swissmedic for high‑containment filling line to seat ADCs and potent biologics
Lonza received Swissmedic approval to operate a new aseptic drug‑product filling line in Stein, Switzerland, designed for highly potent biologics including ADCs. The GMP license upgrades Lonza’s...