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Regulatory and policy push: FDA proposes faster early trials and “domestic-first” incentives
The FDA is using its proposed 2027 budget to lay out policy ideas intended to speed early clinical development in the U.S. and encourage domestic drug manufacturing. FDA Commissioner Marty Makary...
Diagnostics access expands: at-home HPV self-collection gets FDA 510(k) clearance
Waters received FDA 510(k) clearance for its BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay, enabling an at-home workflow for high-risk HPV screening. The test is designed to...
AI-enabled immunology readouts: new single-cell method tracks RNA and protein together
Researchers reported CIPHER-seq, a single-cell platform designed to measure RNA and proteins simultaneously in the same immune cell, aimed at closing the gap between cytokine gene expression and...
Breast cancer imaging: new AI model targets DCE-MRI tumor segmentation
A new AI approach for breast cancer imaging, RST2G, was reported to improve dynamic contrast-enhanced MRI (DCE-MRI) segmentation performance by combining residual-guided spatiotemporal transformer...
Oncology testing expansion: Grail integrates Galleri ordering into Epic EHR
Grail partnered with Epic to integrate its Galleri multi-cancer early detection test into Epic’s electronic health record platforms, allowing clinicians to order the test within standard EHR...
Rare disease therapeutics: For patients with Vykat XR’s success backdrop, gene-to-drug translation continues with targeted platforms
Insilico Medicine announced ISM6200, a selective NR3C1 (glucocorticoid receptor) inhibitor it positions as best-in-class for multiple indications including ovarian cancer, Cushing’s syndrome,...
Clinical trial readout: Daratumumab shows signal in early myeloma stages
The Phase II D-PRISM study reported promising efficacy for daratumumab in early multiple myeloma stages, including high-risk MGUS and low-risk smoldering multiple myeloma. The study is framed as...
Biotech funding: Jeito Capital closes $1.2B fund for independent clinical-stage European biopharma
Jeito Capital, a prominent European biotech investor, raised $1.2 billion for its next fund (Jeito II), positioning it as the largest ever for a fully independent European fund focused on...
Major oncology M&A expands Gilead’s ADC platform
Gilead Sciences has agreed to acquire German biotech Tubulis for $3.15 billion upfront, with total consideration of up to $5 billion, as the company steps up its antibody-drug conjugate (ADC)...
Neurocrine locks in Prader-Willi revenue with Soleno takeover
Neurocrine Biosciences has agreed to buy Soleno Therapeutics for $2.9 billion, positioning the deal to scale Vykat XR (diazoxide choline) in Prader-Willi syndrome. Neurocrine will pay $53.00 per...
ADC financing: Sidewinder raises for bispecific platform
Sidewinder Therapeutics, a San Diego biotech pursuing bispecific and dual-payload ADC designs, has raised a $137 million Series B led by blue-chip investors. The funding will support preparations...
Med-tech diagnostics: Grail integrates Galleri ordering into Epic EHR
Grail has partnered with Epic to broaden ordering access for its Galleri multi-cancer early detection test inside electronic health record workflows. The collaboration enables clinicians using...
Regulatory shift: Waters’ FDA clearance for at-home HPV self-collection
Waters said its BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay received FDA 510(k) clearance, enabling at-home collection to improve access to cervical cancer screening. The test...
Clinical evidence: Duloxetine fails to prevent chemotherapy-induced neuropathy
A randomized clinical trial led through the Alliance for Clinical Trials in Oncology and supported by the National Cancer Institute found that duloxetine did not prevent chemotherapy-induced...
Diagnostics at scale: UCLA blood test targets cfDNA methylation for multiple diseases
UCLA researchers have developed a low-cost blood test, MethylScan, built on cell-free DNA (cfDNA) methylation sequencing to detect multiple cancers and liver-related conditions in a single assay...
Bio-processing and analytics: TriNetX buys Zetta Genomics assets
TriNetX has acquired Zetta Genomics assets, aiming to expand its genomics data management and analytics capabilities for healthcare providers and life science researchers. The move is intended to...
Regulatory modernization: FDA proposes faster US first-in-human pathways
The FDA used its 2027 budget proposal to outline steps intended to shorten the time to first-in-human trials, with an optional, risk-based Investigational New Drug pathway for certain candidates....
AI + clinical ops: CellCarta partners with Lunit for AI pathology in trials
CellCarta and Lunit have partnered to integrate Lunit’s Scope AI pathology tools into clinical trial pathology workflows. The collaboration is designed to help sponsors manage biomarker...
Gilead expands oncology ADC platform with Tubulis takeover
Gilead Sciences moved deeper into antibody-drug conjugates by agreeing to acquire German biotech Tubulis for $3.15 billion upfront and up to $1.85 billion in milestones, with the deal expected to...
Neurocrine buys Soleno for $2.9B to bolster rare disease and endocrinology portfolio
Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion to expand its marketed endocrinology and rare-disease franchise. The deal would add Vykat XR (diazoxide choline), a...