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Latest Biotech News

Oncology — combo data claims versus Keytruda

May 12, 2026

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

May 12, 2026

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

May 12, 2026

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

May 12, 2026

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

May 12, 2026

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

May 12, 2026

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

May 12, 2026

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

May 12, 2026

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

May 11, 2026

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

May 11, 2026

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...

M&A deal to expand AI-powered pathology

May 11, 2026

Roche agreed to acquire PathAI for $750 million upfront to expand AI-powered digital pathology capabilities. The deal targets PathAI’s tools used in pathology workflows and aims to integrate...

Clinical signal for Alzheimer’s drug uptake

May 11, 2026

STAT+ reported that Medicare is spending far less than expected on newly approved Alzheimer’s drugs Leqembi and Kisunla, citing a Centers for Medicare and Medicaid Services spokesperson. The muted...

U.S. FDA guidance update on pregnancy safety studies

May 11, 2026

FDA is finalizing its post-approval pregnancy safety study guidance seven years after publishing a draft, with some changes from the earlier version. The update is designed to reflect evolving...

IND clearance opens door for new IBD therapy candidate

May 11, 2026

Bioscience Co. Ltd. received IND clearance from the FDA for 9MW5211, a candidate intended for treatment of inflammatory bowel disease. The clearance advances the program from preclinical work into...

Financing round for respiratory-focused antibody developer

May 11, 2026

Windward Bio secured $165 million to support clinical trials in asthma, COPD, and additional respiratory and dermatological indications. The company said the funding backs a lead long-acting...

Corporate deal in ophthalmology bispecific antibodies

May 11, 2026

Curacle entered a potential $1.07 billion deal with Memento Medicines, granting Memento exclusive global rights to develop and commercialize preclinical TIE2/VEGF-directed bispecific MT-103 for...

AI platform for antibody triage to reduce screening bottlenecks

May 11, 2026

Nuclera launched an antibody triage service to streamline the transition from AI-driven antibody hit generation to lead selection, targeting a bottleneck in experimental validation. The service...

Precision oncology trial data update impacting investor sentiment

May 11, 2026

enGene’s detalimogene (nonviral gene therapy candidate) reported updated data in its Phase II LEGEND trial in high-risk, BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ...

Digital pathology deal

May 11, 2026

Roche agreed to buy PathAI in a deal structured around $750 million in upfront consideration, aiming to accelerate the use of AI in digital pathology workflows. PathAI supplies technology used by...

Gene therapy in Europe

May 11, 2026

European regulators greenlit Fractyl Health’s clinical test of a GLP-1 gene therapy, as developers race to replace daily or weekly GLP-1 drug dosing with a potentially one-time treatment. The...