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Pancreatic cancer: RAS-directed therapy moves toward US approval
Revolution Medicines said its orally dosed RAS inhibitor daraxonrasib significantly extended survival versus chemotherapy in a Phase 3 trial in metastatic pancreatic ductal adenocarcinoma,...
Big Pharma deals and pipeline building: Lilly pays for dual-payload ADC upside
Eli Lilly agreed to acquire CrossBridge Bio for up to $300 million, aiming to expand its oncology pipeline with dual-payload antibody-drug conjugates designed to deliver two cytotoxic payloads to...
Regulatory policy: FDA drafts gene-editing safety guidance using next-gen sequencing
The FDA released draft guidance describing how to use next-generation sequencing methods to assess safety for genome-edited gene therapy products, focusing on off-target editing and loss of genome...
FDA oversight for peptides: advisors to review compounding restrictions
The FDA began taking the first step toward potentially changing how popular peptide products can be compounded in the US by convening advisors on whether a set of peptides should be allowed for...
Financing and capital markets: Revolution Medicines dominates with $2B public raise
Revolution Medicines priced a $2 billion concurrent stock-and-debt offering, described as among the largest follow-on raises in biotech history, shortly after reporting top-line Phase 3 results...
Biomarker and diagnostic access: Tempus distributes Predicta Biosciences’ myeloma WGS assay
Tempus announced an agreement to distribute Predicta Biosciences’ whole-genome sequencing-based GenoPredicta assay for multiple myeloma. Tempus said GenoPredicta can be used on both peripheral...
Regenerative and infectious disease diagnostics at scale: Oxford Nanopore and Cepheid expand sequencing workflow
Cepheid and Oxford Nanopore entered Phase 2 of a strategic collaboration to develop nanopore sequencing-based pathogen testing workflows using Cepheid GeneXpert systems. The companies said the...
Clinical-stage oncology access: DRUP trial data supports off-label precision in molecular subgroups
A Dutch multicenter team reported responses to off-label genomics-guided targeted drugs and immunotherapies through the prospective DRUP protocol, identifying molecular subgroups with “substantial...
AI in drug discovery at industrial scale: AWS launches Bio Discovery and agentic lab-in-the-loop
Amazon Web Services launched Amazon Bio Discovery, an AI platform designed to accelerate antibody drug discovery by giving researchers direct access to a library of biological foundation models...
Venture funding: Terremoto raises $108M to advance AKT1 covalent inhibitors
Terremoto Biosciences raised $108 million in a Series C to advance small-molecule medicines targeting AKT1, including a lead program for solid tumors defined by specific genetic alterations and a...
Drug development wins and rapid FDA action
Travere Therapeutics’ Filspari (sparsentan) won a fresh FDA milestone, becoming the first fully approved therapy for focal segmental glomerulosclerosis (FSGS). The agency expanded the label based...
Large-scale financing rebounds for public biotechs
Revolution Medicines priced a $2 billion combined stock and debt offering, the largest public financing in the US biotech space since the Covid-era, according to the company’s report. The raise...
Bain Capital reboots immunology pipeline with Beeline Medicines
Beeline Medicines launched out of stealth with plans to develop licensed immunology assets from Bristol Myers Squibb, backed by Bain Capital’s $300 million Series A. The new company is led by...
In vivo CAR-T programs expand for autoimmune disease
Immorna and additional in vivo CAR-T startups moved into first-in-human testing for autoimmune disease, extending a growing push toward therapies that aim to avoid full ex vivo manufacturing....
AI-enabled diagnostics and lab workflows
Leica Biosystems and Indica Labs expanded their digital pathology footprint in the US with the launch of Aperio HALO AP DX software for the Aperio GT 450 DX scanner workflow. The integrated system...
Protein engineering and sensing platform advances
FairJourney Bio opened a new cryo-EM structural biology facility in San Diego designed to strengthen its antibody discovery and development workflow. The facility includes a 300 kV infrastructure...
Terremoto pushes AKT covalent small molecules with new Series C
Terremoto Biosciences raised $108 million in a Series C to advance oral drug candidates targeting AKT, including TER-2013 for solid tumors with specific genetic alterations and TER-4480 for...
Drug-discovery model access expands via Amazon Bio Discovery
Amazon Web Services launched Amazon Bio Discovery, an agentic AI platform designed to speed antibody design with direct access to foundation models and integrated lab partner workflows. The system...
Oncology dealmaking: Eli Lilly buys dual-payload ADC startup CrossBridge Bio
Eli Lilly agreed to acquire CrossBridge Bio in a deal valued at up to $300 million to expand its oncology pipeline in dual-payload antibody-drug conjugates. CrossBridge’s platform is built to...
Regulatory framework for genome editing safety
The FDA released draft guidance on using next-generation sequencing to assess safety risks for genome-edited gene therapy products, focusing on off-target editing and chromosomal integrity. The...