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FDA to unify adverse-event trackers: agency consolidates safety surveillance
The U.S. Food and Drug Administration announced it will consolidate multiple adverse-event reporting systems into a single Adverse Event Monitoring System (AEMS). The agency said the unified...
Nanoparticle mRNA sparks CAR T generation in vivo — Johns Hopkins shows proof in mice
Johns Hopkins Medicine researchers reported a biodegradable nanoparticle that delivers mRNA encoding an anti-CD19 chimeric antigen receptor (CAR) directly to T cells in vivo, producing functional...
Amino acids supercharge LNPs — Biohub finds metabolic tweak boosts mRNA and CRISPR delivery
Researchers at the Chan Zuckerberg Biohub reported that co‑administering a simple three‑amino‑acid cocktail dramatically improved in vivo lipid nanoparticle (LNP) uptake and functional delivery of...
Src kinase flips outside tumor cells — UCSF identifies new pan‑tumor antibody target
Scientists at UCSF discovered that the proto-oncogene Src, long thought to be exclusively intracellular, can appear on the exterior membrane of multiple tumor types through autophagolysosomal...
Largest pediatric cancer structural‑variant atlas released — St. Jude and NCI publish pan‑cancer dataset
St. Jude Children’s Research Hospital and the National Cancer Institute published the first and largest pediatric cancer structural‑variant (SV) dataset in Cancer Cell, offering a pan‑cancer map...
Romiplostim prevents severe chemo thrombocytopenia — global phase 3 shows positive results
A global phase 3 trial led by Mass General Brigham demonstrated that romiplostim reduces rates of chemotherapy‑induced thrombocytopenia (CIT) in patients receiving cytotoxic regimens. The study...
PSMA PET/CT cuts prostate biopsies: PRIMARY2 shows imaging can reduce invasive sampling
PRIMARY2 clinical trial results presented at EAU26 found that PSMA PET/CT imaging substantially reduced the need for invasive prostate biopsies in men with suspected cancer after equivocal or...
Evotec to cut ~800 jobs — multi‑year restructuring shutters four sites
Evotec announced a major restructuring that includes eliminating up to 800 positions—about one‑sixth of its global workforce—and closing four facilities across Europe and the U.S. The company said...
Enodia acquires Kezar’s Sec61 assets — deal nets Kezar $1M upfront plus milestones
Enodia Therapeutics acquired Kezar Life Sciences’ Sec61‑based discovery and development assets in a deal that pays Kezar $1 million upfront and up to $127 million in development, regulatory and...
Novartis spins cardiology RNA programs into Atrium — $270M backing to target genetic heart disease
Aspinout from Avidity’s portfolio, Atrium Therapeutics launched with approximately $270 million in cash and equivalents to advance RNA therapeutics for rare genetic cardiomyopathies. The company...
FDA consolidates safety tracking: one dashboard for drugs and vaccines
The U.S. Food and Drug Administration announced it will merge its fragmented adverse-event reporting systems into a single platform, the Adverse Event Monitoring System (AEMS). Agency officials...
Enodia buys Kezar Sec61 program: $1m now, $127m on milestones
Enodia Therapeutics acquired Kezar Life Sciences’ Sec61-based discovery and development assets in a deal that pays $1 million upfront and up to $127 million in future development, regulatory and...
Evotec cuts 800 jobs – big restructuring to sharpen drug-discovery services
Evotec unveiled a multi-year restructuring named 'Horizons' that will eliminate up to 800 positions—about one-sixth of its workforce—and close four facilities across Europe and the U.S. The...
New in vivo LNP assays pinpoint endosomal escape to guide RNA delivery
Researchers published two complementary Nature Biotechnology reports presenting in vivo methods to quantify endosomal escape of lipid nanoparticles (LNPs). One uses a lysosomal barcoding strategy...
Nanoparticles make CAR T in patients: mRNA particles program T cells in vivo
Johns Hopkins Medicine researchers reported biodegradable targeted polymeric mRNA nanoparticles that program patients’ T cells in vivo to express a CD19 chimeric antigen receptor (CAR). In mouse...
Regenxbio’s DMD program holds: safety clean as pivotal readout approaches
Regenxbio reported consistent, favorable safety signals and functional improvements for its Duchenne muscular dystrophy (DMD) gene therapy candidate ahead of an impending pivotal data readout....
Immune-evasive DNA donors enable kilobase writing—safer path to gene insertion
Two independent teams disclosed complementary advances that make large, gene-sized DNA insertions safer and more scalable. One group described 'INSTALL'—a circular single-stranded DNA donor with a...
Avidity carves out Atrium with $270m; Vima ups Series A to $100m
Avidity Biosciences spun its preclinical cardiac RNA programs into Atrium Therapeutics with roughly $270 million in cash and equivalents to back two AOC-based candidates for rare genetic...
Pfizer shutters Ignite – end of an R&D services arm for startups
Pfizer is winding down its Pfizer Ignite unit, a program that provided advisory and R&D services to early-stage biotech companies. Regulatory disclosures indicate the company is drawing down...
FDA approves Wellcovorin for rare cerebral folate deficiency, not autism
The FDA cleared leucovorin (Wellcovorin) for a specific, genetic form of cerebral folate deficiency (CFD‑FOLR1), reversing earlier public signals that the agency might greenlight broader use for...