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FDA strengthens personalized diagnostics for Tepmetko via expanded companion testing
The FDA approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic for EMD Serono’s Tepmetko (tepotinib), expanding eligible sample types to include both tissue and liquid biopsy...
Regulatory enforcement targets GLP-1 import safeguards
FDA issued a warning letter to Harbin Jixianglong Biotech after inspectors found compliance issues tied to semaglutide API shipments under the agency’s “green list” import controls. The company...
Cell therapy platform momentum: primate data for prion suppressor ST-506
Sangamo Therapeutics presented primate data for ST-506, its AAV-based, one-time therapy designed to suppress PRNP expression for prion disease. The candidate uses a BBB-penetrant zinc finger...
Cancer immunotherapy: cDC1 reprogramming AT-108 advances as durable approach
Asgard Therapeutics described preclinical work supporting AT-108, an adenoviral vector therapy designed to reprogram tumor cells into cDC1-like antigen-presenting cells. The approach uses...
Bioanalytical and CDMO capacity: Thermo expands biomarker lab in Sweden
Thermo Fisher opened a new bioanalytical and biomarker laboratory in Gothenburg, Sweden, placing additional assay and analytical capacity inside GoCo Health Innovation City. The facility is...
AI in drug discovery operations: BMS integrates Claude across enterprise workflows
Bristol Myers Squibb partnered with Anthropic to deploy Claude AI across its global operations, targeting enterprise-wide acceleration in drug discovery and development. BMS said it will integrate...
Clinical research setback in Parkinson’s: Biogen and Denali end LRRK2 program in idiopathic disease
Biogen and Denali Therapeutics discontinued development of their LRRK2 inhibitor program for idiopathic Parkinson’s after a Phase 2b trial missed its primary endpoint. The randomized study...
Diagnostics platform expansion: InSphero acquires PhenoVista
InSphero acquired PhenoVista Biosciences, a cell-based assay services provider focused on high-content imaging and phenotypic assay technologies. The deal is designed to broaden InSphero’s 3D...
Obesity drug approvals and late-stage efficacy readouts
Eli Lilly’s retatrutide kept stacking up obesity wins with topline Phase 3 data that show weight loss across doses in the company’s Triumph-1 program, reported ahead of further data presentations....
FDA moves to expand tissue testing for targeted lung cancer therapy
The FDA approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic for EMD Serono’s Tepmetko (tepotinib) to identify metastatic non-small cell lung cancer patients with MET exon 14...
AI in drug discovery and enterprise execution
Bristol Myers Squibb moved its AI program beyond chatbots, announcing a partnership with Anthropic to deploy Claude across its global operations. BMS said it will embed the system across research,...
Precision oncology diagnostics: broader liquid CDx footprint gets FDA approval
Guardant Health secured FDA approval for its upgraded Guardant360 Liquid CDx, expanding the test’s clinical utility with a reported 100-fold larger genomic footprint compared with the prior...
Lung cancer: ADC plus Keytruda posts randomized Phase 3 progression advantage
Merck and Kelun-Biotech reported a Phase 3 readout showing sacituzumab tirumotecan (sac-TMT) combined with Keytruda cut the risk of disease progression or death by 65% versus Keytruda alone in...
Parkinson’s genetics: LRRK2 therapy fails to slow disease in randomized trial
Biogen and Denali Therapeutics said their investigational Parkinson’s therapy targeting LRRK2 failed in a randomized trial to slow neurodegeneration. The study randomized 648 adults with...
Gene therapy safety: trial closure after patient death leaves mechanism unresolved
Capsida Biotherapeutics confirmed it closed its SYNRGY Phase I/II gene therapy trial for STXBP1-related DEE after the previously reported death of a child who received CAP-002. The company cited...
Company dealmaking: Lilly expands genetics pipeline via DNA delivery acquisition
Eli Lilly agreed to buy Engage Bio, a preclinical-stage startup developing non-viral DNA delivery technology, as the company continues expanding in genetic medicines. The deal includes $202...
Cardiovascular interventions: Cagent raises $41M to expand coronary IVL platform
Cagent Vascular closed an oversubscribed $41 million Series D to advance its dual-modality intravascular lithotripsy platform toward coronary commercialization and further clinical testing. The...
Biotech M&A: Liminatus to buy InnocsAI for $320M stock for next-gen CAR-T pipeline
Liminatus Pharma agreed to acquire CAR-T biotech InnocsAI in a stock deal valued at $320 million, gaining access to an oncology pipeline centered on bivalent CD19xCD22 CAR-T. InnocsAI’s lead asset...
GLP-1 supply-chain compliance under FDA import restrictions
The FDA issued a warning letter to Harbin Jixianglong Biotech after inspections found the company allegedly attempted to bypass recently introduced GLP-1 receptor agonist import safeguards for...
First randomized phase 3 win for an ADC–PD-1 frontline lung cancer combo
Merck and Kelun-Biotech reported Phase 3 results for sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (Keytruda) in treatment-naïve, PD-L1–positive non-small cell lung cancer, showing a 65%...