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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...
mRNA delivery system restores PTEN — sharpens colorectal immunotherapy
Researchers developed a biomimetic mRNA delivery platform that restores PTEN expression in colorectal tumor models and enhances anti‑tumor immune responses. The system uses targeted delivery...
Intranasal nanogel vaccine slows HPV‑driven cervical tumors in models
Chiba University researchers published preclinical results for a cationic nanogel intranasal therapeutic vaccine targeting HPV16 E7 oncoprotein in Science Translational Medicine. The cCHP‑E7 +...
Non‑GM bovine cell immortalization clears a major cultivated‑meat hurdle
Scientists at Hebrew University and Believer Meats reported a Nature paper describing a non‑genetically modified method to immortalize bovine cells by activating telomerase and PGC1α pathways. The...
Merck pays $9.2B for Cidara — bets on season‑long flu prevention
Merck agreed to acquire Cidara Therapeutics for $9.2 billion to secure CD‑388, a late‑stage long‑acting antiviral being developed as seasonal influenza prophylaxis. Cidara’s CD‑388, a drug‑Fc...
Pfizer closes up to $10B Metsera deal — adds fast‑acting amylin, GLP assets
Pfizer completed an acquisition of Metsera valued at up to $10 billion to broaden its obesity and metabolic portfolio, securing both a long‑acting GLP‑1 asset and a fast‑acting amylin analog. The...
FDA clears Komzifti — menin inhibitor approved for NPM1‑mutant AML
The U.S. Food and Drug Administration approved ziftomenib (Komzifti) from Kura Oncology and Kyowa Kirin to treat relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutations. The...
BMS/J&J next‑gen blood thinner fails phase 3 — milvexian misses endpoint
Bristol Myers Squibb and Johnson & Johnson halted a phase III trial of their factor XIa inhibitor milvexian in acute coronary syndrome after an interim analysis showed the drug was unlikely to...
Lundbeck interrupts Alkermes‑Avadel deal — unsolicited higher bid tops earlier offer
Lundbeck submitted an unsolicited, higher cash plus contingent‑value offer for Avadel Pharmaceuticals, complicating Alkermes’ previously announced $2.1 billion takeover agreement. Lundbeck’s...
Medicxi closes €500M Fund V — doubles down on asset‑centric biotech bets
Medicxi secured €500 million for Fund V to back asset‑centric biotech companies across Europe and select opportunistic later‑stage investments. The raise follows Medicxi’s track record of creating...
EMA panel endorses five new medicines — gene therapy for Wiskott‑Aldrich included
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of five new products, among them a gene therapy for Wiskott‑Aldrich syndrome developed by...
AI pushes into discovery and diagnostics — DeepTarget predicts drug mechanisms; CarbaDetector flags carbapenemase
Researchers unveiled two AI advances: DeepTarget, a deep‑learning platform that predicts anti‑cancer mechanisms of small molecules and potential targets, and CarbaDetector, a machine‑learning...
Scientists immortalize bovine cells without genetic modification — cultivated beef milestone
Researchers at Hebrew University and Believer Meats reported a non‑genetically modified method to induce stable, self‑renewing bovine cell lines by activating telomerase and PGC1α, enabling...
Genetically edited pig kidney sustains function for 61 days in human recipient — xenotransplant advance
Researchers reported that a gene‑edited pig kidney functioned in a brain‑dead human recipient for 61 days, with multi‑omic and physiological monitoring documenting graft performance and host...
Merck pays $9.2B for Cidara: buys late‑stage flu preventive
Merck agreed to acquire Cidara Therapeutics for $9.2 billion to secure CD388, a late‑stage, long‑acting antiviral candidate for seasonal influenza. The deal, announced by Merck, pays a substantial...
Pfizer closes up to $10B Metsera deal: fast‑acting amylin added
Pfizer completed its acquisition of Metsera for up to $10 billion, securing the biotech’s obesity assets including a long‑acting GLP‑1 and a fast‑acting amylin analog. The deal closes a...
FDA clears Komzifti: Kura/Kyowa’s menin inhibitor wins in NPM1 AML
The U.S. Food and Drug Administration approved ziftomenib (Komzifti) from Kura Oncology and Kyowa Kirin to treat relapsed or refractory acute myeloid leukemia with NPM1 mutations. The approval was...