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In vivo CAR‑T reduces liver fibrosis in preclinical MASH models
Scientists at the Icahn School of Medicine at Mount Sinai reported that CAR‑T cells generated in vivo—designed to eliminate fibroblast activation protein (FAP)‑expressing stellate...
FDA urges long‑term follow‑up for CAR‑T use in autoimmune disease
Senior FDA officials, including Vinay Prasad of CBER, published recommendations urging drug developers to conduct long‑term monitoring when using CAR‑T therapies to treat autoimmune conditions....
PacBio sells short‑read assets to Illumina for $48.1M — sharp strategic shift
Pacific Biosciences sold select short‑read sequencing intellectual property and related assets to Illumina for $48.1 million, signaling PacBio’s renewed focus on long‑read sequencing and optics...
FDA opens PreCheck pilot to speed US prescription drug manufacturing builds
The U.S. Food and Drug Administration launched its PreCheck pilot program, accepting applications from biopharma companies seeking to relocate or build prescription drug manufacturing facilities...
University of Pittsburgh releases HemoLens: open‑source hemodynamics tool
Researchers at the University of Pittsburgh unveiled HemoLens, an open‑source platform designed to assess vascular hemodynamics at a fraction of the cost of commercial systems. HemoLens aims to...
AI mammography reduces interval cancers 12% in 100,000‑woman Lancet trial
A randomized study published in The Lancet tested ScreenPoint Medical’s Transpara Detection AI in breast‑cancer screening for over 100,000 women and found a 12% reduction in interval cancers...
Novo’s CagriSema Beats Semaglutide: Phase 3 Diabetes Readout
Novo Nordisk reported Phase 3 results showing its next‑generation metabolic combination, CagriSema (semaglutide + cagrilintide), reduced blood sugar and produced greater weight loss than...
MGI Acquires BGI Spatial and Nanopore Units: Sequencing Consolidation
MGI Tech filed disclosures that it will acquire two BGI Group spinouts—STOmics (spatial biology Stereo‑Seq commercialization) and CycloneSeq (BGI nanopore platforms)—for RMB 365.7 million (~$52.6...
Johns Hopkins Tests Epigenetic Instability to Spot Early Cancers
Researchers at Johns Hopkins Kimmel Cancer Center published a liquid‑biopsy approach that measures epigenetic variability—random fluctuations in DNA methylation—to detect early‑stage cancers....
MIT Unveils Portable Ultrasound: Aiming at Earlier, More Accessible Breast Screening
MIT researchers revealed a compact ultrasound system designed to make breast imaging more portable and accessible for higher‑risk populations. The platform combines a small probe with a data...
Natera Files Signatera PMA: MRD Companion Diagnostic for Bladder Cancer
Natera submitted a premarket approval (PMA) application to the US Food and Drug Administration for its Signatera CDx circulating tumor DNA assay as a companion diagnostic to guide adjuvant use of...
Sanegene’s RNAi Chemistry Attracts Big Pharma: $200M Upfront Deals
SanegeneBio agreed commercial licenses with major pharma players for RNAi assets, with Genentech (Roche) paying $200 million upfront for at least one candidate and larger potential milestone...
PacBio Narrows Focus: Sells Short‑Read Assets to Illumina for $48.1M
Pacific Biosciences sold select short‑read sequencing intellectual property and assets (including technology from Apton/Omniome Onso) to Illumina for $48.1 million, saying the move sharpens its...
Twist’s Revenue Rises 17% as AI‑Enabled Discovery Drives New Orders
Twist Bioscience reported fiscal Q1 revenue of $103.7 million, a 17% year‑on‑year increase, and credited growth to its DNA synthesis and protein solutions business and new AI‑enabled therapeutic...
GSK Returns RNA Editing Rights to Wave: Wave Reclaims Lead Asset
GSK returned global rights for Wave Life Sciences’ RNA editing program WVE‑006 (AATD) to Wave, removing itself as development partner and restoring full control to Wave. Wave said it will pursue...
FDA Pauses Regenxbio Trials After Patient Cancer Case: Clinical Holds Raised
Regulatory scrutiny has halted parts of Regenxbio’s gene therapy program after a patient in one study developed cancer, prompting the FDA to place holds on two trials. The agency’s action requires...
Twist’s AI push pays off: Q1 revenue climbs 17%
Twist Bioscience reported fiscal Q1 revenue of $103.7 million, a 17% year‑over‑year increase driven by growth in DNA synthesis and an emergent AI‑enabled therapeutic discovery business. The...
PacBio pares assets: short‑read tech sold to Illumina for cash
Pacific Biosciences sold select short‑read sequencing intellectual property and related assets to Illumina for $50 million in cash, receiving about $48.1 million net after contingent payments,...
Roche/Genentech bet on Sanegene RNAi: multibillion‑dollar upside
SanegeneBio struck licensing agreements with Roche/Genentech for an RNAi program that include a $200 million upfront payment and potential for up to roughly $1.5–1.7 billion in development and...
Natera seeks FDA PMA for Signatera MRD test in bladder cancer
Natera submitted a premarket approval (PMA) application for its Signatera CDx assay to the U.S. Food and Drug Administration as a companion diagnostic to guide adjuvant treatment decisions with...