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All-oral AML regimen in older patients (ASCERTAIN V)
An all-oral regimen for older adults with acute myeloid leukemia moved into focus after results from the ASCERTAIN V trial. The phase 1/phase 2 study is designed to reduce the logistical burden of...
Onco-immune pipeline expansion via automated TSC-101 manufacturing
Cellares and TScan Therapeutics agreed to evaluate automated manufacturing for TSC-101, TScan’s TCR-T therapy candidate aimed at residual disease and relapse prevention in acute myeloid leukemia...
FDA breakthrough designation for invasive mold liquid biopsy
The FDA granted Zepto Life Technology a Breakthrough Device designation for its FungiFlex Mold Panel, a plasma-based liquid biopsy intended to detect invasive mold infections by analyzing...
AI collaboration expands RNAi therapeutic discovery
Alnylam expanded its discovery-focused AI partnership with Inceptive, signing a three-year collaboration valued at up to $2 billion with $30 million upfront in cash and equity. The companies plan...
Cell therapy manufacturing scale-up and AAV analytics automation
NanoMosaic and Solid Biosciences announced a comarketing agreement aimed at improving genetic drug delivery and manufacturing analytics for AAV gene therapies. The collaboration pairs NanoMosaic’s...
Breakthrough immune cell engineering for ovarian cancer targeting (T cell engagement)
Creatv Bio and Neovia Oncology agreed to evaluate Creatv’s LifeTracDx liquid biopsy technology in clinical studies of Neovia’s drug-resistant solid tumor program, NEV-801. The monitoring test uses...
New clinical and regulatory direction for global trial quality (WHO)
The World Health Organization took steps to strengthen clinical trial design and implementation with an online course intended to support researchers globally, citing concerns about the integrity...
AI and high-definition immune profiling funding push
IMU Biosciences raised an expanded £53M Series A round to scale high-definition immune profiling technology and advance clinical programs. The company said the funding supports operational...
Phase 3 RAS targeting delivers major survival lift in pancreatic cancer
Revolution Medicines’ daraxonrasib, a pan-RAS inhibitor, delivered a clinically meaningful overall survival benefit in a Phase 3 trial in advanced pancreatic ductal adenocarcinoma, according to...
FDA breakthrough designation for Zepto Life’s direct-from-blood invasive mold panel
Zepto Life Technology received US FDA breakthrough device designation for its FungiFlex Mold Panel aimed at invasive mold infections. The assay detects and distinguishes fungal cell-free DNA...
Lilly expands genetic medicines with Ascidian RNA exon editing for inherited kidney disease
Eli Lilly struck a collaboration with Ascidian Therapeutics to develop RNA exon editor therapies for inherited kidney diseases, with deal value potentially reaching $1.9 billion. Lilly will gain...
Cell therapy debut: Legend reports first in vivo CAR-T signal in lymphoma
Legend Biotech disclosed early clinical data from an investigator-initiated trial of its in vivo CAR-T therapy in lymphoma, reporting results across 12 patients. The company said the treatment...
AI dealmaking: Alnylam and Inceptive collaborate on RNAi foundation models
Alnylam and Inceptive Nucleics announced a three-year strategic collaboration focused on using AI foundation models to accelerate RNAi therapeutics discovery. The partnership is valued at up to $2...
Clinical diagnostics funding: Mammogen raises Series A for mRNA blood test aligned with breast density policy
Mammogen raised up to $30 million in a Series A equity round to support clinical testing of genTRU-breast, its mRNA-based blood assay designed for earlier detection of breast cancer. The company...
Regulatory and trial oversight shift: WHO launches training to strengthen trial design
The World Health Organization is moving to strengthen clinical trial design and implementation through a new online training course launched as part of its science capacity efforts. WHO said the...
China regulatory progress: NMPA clears CSPC’s mRNA-LNP dual-target CAR T for SLE
CSPC Pharmaceutical Group secured clinical trial clearance in China for SYS-6063, an mRNA-LNP-based dual-target CAR T-cell injection for relapsed or refractory systemic lupus erythematosus. The...
Sickle cell setback: Fulcrum ends pociredir program after FDA raises cancer-risk concerns
Fulcrum Therapeutics discontinued development of its sickle cell disease candidate pociredir after the FDA raised heightened concerns about risks and benefits. The company said the FDA concluded...
New investment: NewLimit closes $435M round ahead of first-in-human liver medicine
Longevity startup NewLimit raised $435 million at a valuation above $3 billion, with plans to start its first clinical trial in 2026 for a liver-focused therapeutic. The Series C financing was led...
In-vivo CAR-T data boosts Legend Biotech momentum
Legend Biotech disclosed early clinical data for an in vivo CAR-T approach in non-Hodgkin’s lymphoma, reporting that the therapy reduced or eliminated signs of disease in all treated recipients....
FDA scrutiny derails Fulcrum’s sickle cell PRC2 inhibitor program
Fulcrum Therapeutics is scrapping development of its lead sickle cell disease candidate, pociredir, and will pursue a strategic review after the FDA raised heightened concerns about risks and...