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Health Canada to reclassify cloned‑animal products: silent policy shift
Health Canada plans to remove foods derived from cloned cattle and swine from its "novel foods" list, a policy change that would end mandatory pre‑market safety reviews and public disclosure for...
Human kidney organoids scaled for porcine transplant research
Researchers reported a systematic process to produce human kidney organoids intended to advance porcine‑based xenotransplantation and regenerative‑medicine studies, publishing methods that aim to...
Turbocharged Cas9 nuclear entry: internal NLS insertions boost editing
Researchers at UC Berkeley’s Innovative Genomics Institute reported a protein‑engineering strategy that inserts multiple nuclear localization signals into internal loops of Cas9 to increase...
Pfizer Sues to Block Novo Bid—Metsera Deal in Limbo
Pfizer filed suit in Delaware to enforce its September acquisition agreement with obesity biotech Metsera and to block Novo Nordisk’s competing proposal. Pfizer alleges Metsera’s board and Novo...
FDA Halts Intellia's CRISPR Trials After Liver Complications
The FDA placed a clinical hold on Intellia’s two Phase 3 studies of nexiguran ziclumeran (nex‑z), a CRISPR‑based therapy for transthyretin amyloidosis, following liver safety signals. The agency’s...
Gene Therapy 'Cure' for ADA‑SCID: 95% Success in Multi‑Year Follow‑Up
A joint UCL–UCLA team reported multi‑year follow‑up showing approximately 95% success and no serious safety signals for UCL/A‑ADA gene therapy in children with ADA‑SCID, according to a New England...
Human Kidney Organoids Scaled—Porcine Transplant Demonstrates Feasibility
Researchers published a Nature Biomedical Engineering study describing a reproducible method to produce thousands of human kidney organoids and the first experiments integrating those organoids...
Moderna Faces Downturn—Restructuring as Covid Windfall Erodes
A detailed review of Moderna’s trajectory documents major commercial and strategic challenges since its Covid vaccine peak: revenue declines for its pandemic shot, layoffs, restructurings and...
Bird flu spillovers revive phage therapy and vaccine research
Rising HPAI (H5N1) spillovers into livestock and occasional human cases have renewed interest in bacteriophage therapeutics and phage‑based vaccine platforms. A review citing CDC and USDA figures...
FDA Commissioner Signals New Deregulatory Moves—Industry Watches
FDA Commissioner Marty Makary publicly signaled forthcoming “deregulatory” actions, expanding on the agency’s recent relaxation of biosimilar trial requirements. Makary framed the steps as agency...
AI Models Close In on Binding Affinity—Boltz‑2 and Physics‑Grounded LQMs
Researchers from MIT and partners released Boltz‑2 and highlighted the rise of physics‑grounded large quantitative models (LQMs) for drug discovery. Boltz‑2 led binding‑affinity prediction at...
IL‑12 Nanoparticles Eradicate Metastatic Ovarian Tumors in Mice
MIT researchers reported in Nature Materials that polymer‑coated nanoparticles delivering IL‑12 directly to ovarian tumors, when combined with immune checkpoint inhibitors, eliminated metastatic...
Myeloid IFNγ Signaling Identified as Checkpoint Resistance Lever in Kidney Cancer
Dana‑Farber investigators described a mechanism of resistance to immune checkpoint inhibitors in renal cell carcinoma driven by interferon‑gamma signaling within tumor‑associated myeloid cells....
Pfizer moves to enforce Metsera deal – Delaware court fight begins
Pfizer filed suit in Delaware against Metsera and Novo Nordisk, alleging breach of a September merger agreement and seeking to block Metsera from terminating the Pfizer buyout while Novo pursues a...
FDA halts Intellia CRISPR trials – liver safety probe
The U.S. Food and Drug Administration has placed clinical holds on Intellia’s Phase 3 studies of nexiguran ziclumeran (nex‑z), a CRISPR‑based gene editing therapy for transthyretin amyloidosis,...
Gene therapy achieves 95% success in ADA‑SCID follow‑up – UCL and UCLA
A joint UCL–UCLA team reported multi‑year follow‑up showing a gene therapy approach restored immune function in 95% of treated children with ADA‑SCID, with no serious long‑term safety signals...
Porcine kidneys infused with human organoids...first scalable transplant tests
Researchers demonstrated a scalable workflow to generate thousands of human kidney organoids and integrate them into porcine kidneys during ex vivo normothermic perfusion. Teams at the Institute...
Thermo Fisher agrees to buy Clario for $8.88 billion – data and endpoints play
Thermo Fisher Scientific announced a definitive agreement to acquire Clario Holdings for $8.88 billion in cash to expand its clinical‑trial data and endpoint services. The deal aims to combine...
Moderna’s post‑vaccine pivot falters – restructuring and lost contracts
Moderna is facing a deep strategic inflection as Covid‑vaccine sales wane and promised mRNA pipeline successes have yet to materialize. The company has cut costs, disclosed layoffs and...
AI models push binding‑affinity prediction — Boltz‑2 and physics‑grounded LQMs
Researchers and industry teams reported advances in AI‑driven drug discovery, including open‑source models such as Boltz‑2 and physics‑informed large quantitative models (LQMs) that significantly...