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Roche buys PathAI to accelerate AI digital pathology inside pharma workflows
Roche announced it will acquire PathAI in a deal valued at $750 million upfront, aiming to expand AI-powered digital pathology capabilities for pathology labs and biopharma development. PathAI’s...
Gene therapy setbacks and investor repricing in nonviral delivery
enGene’s stock tumbled after updated Phase II LEGEND trial data for its nonviral gene therapy candidate detalimogene voraplasmid in high-risk BCG-unresponsive nonmuscle invasive bladder cancer....
AAV redosing pressure grows as ASGCT spotlights one-and-done constraints
ASGCT highlighted a core challenge for AAV gene therapy: redosing constraints driven by pre-existing immunity and immune responses that can limit future administrations. In a roundup of...
FDA clears an abdominal sensor expanding multichannel urodynamics
Bright Uro received FDA 510(k) clearance for the Glean abdominal sensor, expanding the Glean urodynamics system to support multichannel urodynamic studies. The sensor enables clinicians to capture...
GSK secures siRNA cardiovascular rights from SiranBio for ALK7 target
GSK took rights to a cardiovascular siRNA program from China-based SiranBio, centered on ALK7 knockdown linked to reductions in visceral fat and cardiovascular risk markers. The agreement grants...
Windward Bio raises $165M to push long-acting respiratory antibodies into trials
Windward Bio raised $165 million to support clinical testing of its respiratory antibody programs, positioning the company for trials in asthma, COPD, and related inflammatory indications. The...
New AI gene-ordering platform targets faster, more reliable research execution
Genewiz launched Gene Synthesis 2.0, upgrading how researchers design and order genes through a faster, packaged ordering experience and updated codon optimization. The platform includes Sprint,...
Immunology and platform scaling: Nuclera launches antibody triage service
Nuclera introduced an antibody triage screening service designed to speed the transition from AI or in silico hit generation to lead selection and mammalian validation. The service screens large...
Regulatory approval — ultra-rare fusion cancer
Partner Therapeutics’ Bizengri (bispecific antibody) became the first FDA-approved therapy for advanced cholangiocarcinoma driven by NRG1 gene fusions, marking a regulatory milestone for a...
M&A — Roche buys PathAI to scale AI in pathology
Roche agreed to acquire PathAI in a deal valued at $750 million upfront, aiming to accelerate AI-powered digital pathology across pathology laboratories and biopharma workflows. The transaction...
Oncology — combo data claims versus Keytruda
San Diego biotech Inhibrx said its OX40-keytruda combination approach shrank more tumors than Merck’s Keytruda alone in an early look at midphase data. The company framed the result around its...
AI for protein engineering — explainability and safer design
Multiple teams focused on AI-driven protein design are pushing toward explainability and safer deployment, with research highlighting how current protein language-model workflows can be made more...
Digital pathology — AI de-risking development plus a parallel diagnostic use case
AI is increasingly being used to de-risk both therapeutic development and companion diagnostic pathways, with digital pathology and model-driven analyses moving closer to trial decision points....
Gene therapy manufacturing — stable producer cell line platform
VIVEbiotech expanded its lentiviral vector manufacturing toolkit with EvoLVcell, a stable producer cell line generation platform aimed at cutting batch-to-batch variability. The platform is...
Gene therapy — GLP-1 gene therapy trial cleared in Europe
European regulators cleared Fractyl Health’s clinical test of a GLP-1 gene therapy approach, reflecting continued movement toward one-time treatments that could reduce reliance on chronic GLP-1...
HIV — mapping antibody escape pathways
Researchers used thousands of parallel viral selection experiments to build a comprehensive map of how HIV-1 develops resistance to broadly neutralizing antibodies 3BNC117 and 10-1074. The work,...
Cell fate AI — RegVelo links gene regulatory dynamics to development and disease
Stowers Institute, Helmholtz Munich, Technical University of Munich, and the University of Oxford unveiled RegVelo, an AI model designed to infer gene-regulatory networks driving single-cell fate...
AI in pandemic preparedness — CEPI’s 100-day prediction engine
CEPI unveiled how it is applying AI to pandemic prediction through an effort aimed at meeting a “100-day mission” after identifying a pandemic threat. Speaking at BioProcess International Europe...
Regulatory approval for mutation-defined oncology therapy
Partner Therapeutics’ Bizengri (bispecific antibody) has received FDA approval for advanced cholangiocarcinoma driven by NRG1 gene fusions, marking the first approved therapy for this ultra-rare...
AI-driven pandemic preparedness using vaccination timelines
CEPI has unveiled an AI-powered “pandemic preparedness engine” aimed at accelerating the path from threat identification to vaccine readiness under its 100-day mission. Speaking at BioProcess...