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Next‑gen blood thinner milvexian fails key trial — anticoagulation program hit
Bristol Myers Squibb and Johnson & Johnson announced a Phase III futility readout in their acute coronary syndrome trial of milvexian, a selective Factor XIa inhibitor, and will halt that study....
Medicxi raises €500M fund — backers target creation‑stage biotech
European venture firm Medicxi closed a €500 million Fund V focused on company creation and selective later‑stage investments, according to the firm. The vehicle targets product‑focused startups...
AMP issues draft guidelines on cancer sequencing variant interpretation
The Association for Molecular Pathology (AMP) released draft guidelines for interpreting and reporting cancer sequencing variants, covering biomarkers that predict therapy response or resistance,...
Merck snaps up Cidara for $9.2B — late-stage flu antiviral in hand
Merck agreed to acquire Cidara Therapeutics for about $9.2 billion to secure CD388, a long-acting antiviral designed to prevent seasonal and pandemic influenza. CD388 — a small-molecule...
FDA narrows Elevidys label — boxed warning, ambulatory restriction added
The FDA revised the prescribing information for Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys, adding a boxed safety warning and restricting use to ambulatory patients. The agency...
Factor XIa program stumbles — next‑gen blood thinner fails Phase 3 readout
Bristol Myers Squibb and Johnson & Johnson halted a Phase III trial of their factor XIa inhibitor milvexian after an interim analysis showed the study was unlikely to meet its primary endpoint in...
New AAV variants boost vascular gene delivery — vascular transduction improved
Researchers led by Maria Stamataki reported discovery of engineered adeno‑associated virus (AAV) variants that markedly improve transduction of human vascular endothelial cells. The work,...
Prime‑editing inversion (PIE) enables chromosome‑scale DNA rearrangements
A new genome engineering method, Prime‑Editing‑Based Inversion with Enhanced Performance (PIE), allows researchers to induce large chromosomal inversions in mammalian cells with improved...
Intranasal nanogel therapeutic vaccine slows HPV‑driven cervical cancer in animals
Chiba University researchers published preclinical data in Science Translational Medicine on a cationic nanogel‑based intranasal vaccine targeting HPV16 E7 oncoprotein. The cCHP‑E7 + c‑di‑AMP...
Terasaki, Caltech land $2.8M CIRM grant to model early human embryo formation
The Terasaki Institute for Biomedical Innovation and Caltech secured a $2.8 million Discovery Stage Research grant from CIRM to advance studies of early human embryo formation. The funded project...
Volta Labs, NEB partner to automate NGS library prep on Callisto
Volta Labs and New England Biolabs struck a partnership to integrate NEBNext library prep reagents with Volta’s Callisto automated microfluidic sample preparation platform. The collaboration...
Singleron wins China medical device registration for automated single‑cell platform
Singleron Biotechnologies received Class II medical device registration from China’s NMPA for Matrix Neo, an automated single‑cell processing platform that performs cell isolation, lysis, and mRNA...
Non‑GM immortalization opens door to scalable cultivated beef
Researchers at Hebrew University and Believer Meats reported a Nature paper describing a non‑genetic method to induce stable, long‑term self‑renewal in bovine cells by activating telomerase and...
Merck stakes $9.2B on Cidara’s long‑acting flu candidate
Merck announced a definitive agreement to acquire Cidara Therapeutics for $9.2 billion to secure CD388, a long‑acting, strain‑agnostic antiviral designed to prevent influenza. Cidara’s CD388...
Lundbeck jumps into Avadel bidding war — Alkermes on edge
A competing offer from Lundbeck has disrupted Alkermes’ earlier agreement to buy Avadel Pharmaceuticals, triggering a potential bidding contest for Avadel’s sleep disorder assets. Lundbeck’s...
FDA narrows Elevidys label: boxed warning added
The U.S. Food and Drug Administration revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys, adding a boxed safety warning and limiting use to ambulatory patients. The...
CHMP backs five new products — EMA advances key filings
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended five new products for approval, according to industry reports. Recommendations include a gene‑therapy...
Charity drives EU approval push for Wiskott‑Aldrich gene therapy
After being dropped by two commercial partners, Fondazione Telethon shepherded Waskyra (etuvetidigene autotemcel) — an ex‑vivo autologous hematopoietic stem‑cell gene therapy for Wiskott‑Aldrich...
AMP drafts cancer‑sequencing reporting rules; AI diagnostics featured
The Association for Molecular Pathology’s AMP Group released draft guidelines for interpreting and reporting cancer sequencing variants, adding language on biomarkers for therapy response, liquid...
Engineered AAV variants and assay fixes sharpen gene‑therapy toolbox
Two linked advances address translational bottlenecks in AAV gene therapy: researchers reported engineered AAV variants that improve transduction of human vascular endothelial cells, and a...