Get the Daily Brief
Latest Biotech News
Obesity deals and licensing
Genentech has struck a major licensing agreement with Hanmi Pharmaceutical for HM17321, a long-acting urocortin-2 analog designed to reduce fat mass while preserving muscle. Hanmi will receive...
Alzheimer’s diagnostics and biomarker testing
Roche and Eli Lilly have received US FDA clearance for an Alzheimer’s blood test targeting phospho-tau 217P. The Elecsys Phospho-Tau (217P) Plasma assay is intended to identify amyloid pathology...
US gene therapy safety holds and clinical program disruption
FDA has placed another clinical hold on Regenxbio’s Hunter syndrome AAV gene therapy, RGX-121, after investigators found asymptomatic spine MRI masses in five patients enrolled in the Campsiite...
CAR-T toxicity and mechanism concerns
A study published in Nature Cancer highlights a metabolic mechanism that may help explain why CAR-T activity can wane after infusion: iron-driven ferroptosis undermines engineered T-cell function...
Cancer immunotherapy and checkpoint regulation in lymphoma
Researchers report that blocking KDM5A and KDM5B, chromatin-regulating enzymes, can strengthen antitumor innate immune responses in HHV-8-positive B-cell lymphomas (Kaposi’s sarcoma-associated...
Hepatocellular carcinoma treatment combinations
A multicenter, open-label phase trial reports promising activity for a combination approach in unresectable liver cancer using cadonilimab, lenvatinib and TACE. The study focuses on hepatocellular...
NfL testing harmonization across platforms
A retrospective single-center study in multiple sclerosis finds that plasma neurofilament light chain (pNfL) results are strongly correlated between Roche’s Elecsys NfL assay and Fujirebio’s...
Biotech startups and data infrastructure funding
OmicsBank has raised $2.25 million to expand access to overseas patient data for biopharma training and research. The funding reflects the expanding commercial value of health data pipelines for...
FDA regulatory operations and oversight for gene and device therapies
FDA has issued or extended multiple regulatory actions touching advanced therapies, including a delay of Capricor’s deramiocel decision date to review new data tied to a refined indication. The...
Biotech venture and regional ecosystem signals in Massachusetts
Massachusetts’ biotech workforce and funding picture has shifted as the state appears to be rebounding from earlier headwinds. MassBio’s Industry Snapshot reports the Massachusetts biopharma...
Oncology / Immunotherapy
Moderna and Merck reported positive Phase III results for their individualized neoantigen vaccine intismeran autogene in the INTerpath-001 trial, improving recurrence-free survival and distant...
Regulation / FDA actions
The FDA extended its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy candidate deramiocel, deferring a decision after a negative advisory committee vote. In parallel, the...
Gene therapy / Safety and holds
Regenxbio disclosed that it no longer expects to file for FDA approval of its Hunter syndrome gene therapy RGX-121 in the near future after the program received a second clinical hold this year....
Dealmaking / M&A
Ambros Therapeutics and Werewolf Therapeutics agreed to a definitive merger that pairs Werewolf’s listing vehicle with Ambros’s later-stage bisphosphonate neridronate for complex regional pain...
Diagnostics / Biomarkers
Roche and Eli Lilly received U.S. FDA clearance for the Elecsys Phospho-Tau (217P) Plasma blood test, which is designed to identify amyloid pathology associated with Alzheimer’s disease. The assay...
Immuno-oncology / Cellular biology
New research identified a cancer-associated fibroblast population in lung tumors that coordinates immune suppression by directing regulatory T-cell (Treg) positioning. Published in Nature...
Cell therapy / CAR-T mechanisms
A Nature Cancer study reports that iron-driven ferroptosis can weaken CAR-T cell function and reduce antitumor effectiveness. The work frames ferroptosis—a lipid-peroxide-linked, iron-dependent...
Biotech funding / Market structure
MassBio said young Massachusetts biotech companies are missing out on a venture funding rebound, with seed and Series A dynamics moving in opposite directions. The report indicates that funding is...
Rare disease / Gene therapy business risk
Cellares, a cell therapy manufacturing specialist, announced layoffs of 100 employees after an unnamed large pharmaceutical customer terminated a contract. The company characterized the...
Diagnostics / Global regulatory pathway
WHO opened a prequalification pathway for interferon gamma release assays (IGRAs) and targeted next-generation sequencing (tNGS)-based tuberculosis in vitro diagnostics, enabling independent...