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Mass‑spec scales multiomics: instruments boost throughput and depth
Mass spectrometry vendors pushed new hardware and workflows—such as the Orbitrap Astral Zoom MS—raising throughput to hundreds of samples per day and improving depth to measure ~8,000 proteins per...
Regulatory pivot: FDA signals deregulatory moves as key PDUFAs loom
FDA Commissioner signaled forthcoming 'deregulatory' actions following the agency’s relaxation of some biosimilar trial requirements, indicating further shifts imminently. Separately, industry...
Metsera M&A fight erupts: Pfizer sues as Novo tops bid
Pfizer moved to block Novo Nordisk’s unsolicited takeover attempt for obesity biotech Metsera after Novo lodged a higher bid, escalating a high‑stakes M&A battle in the obesity drug market. Pfizer...
FDA halts Intellia’s CRISPR trials – liver safety alarm
The FDA placed a formal clinical hold on two Phase 3 studies of Intellia Therapeutics’ CRISPR editing candidate nexiguran ziclumeran (nex‑z) after a severe liver adverse event prompted the company...
UCL–UCLA gene therapy posts milestone: durable ADA‑SCID cures reported
A collaborative UCL and UCLA gene therapy program reported durable immune reconstitution in children with ADA‑SCID, achieving reported success rates near 95% with no long‑term safety signals in...
Human kidney organoids scaled and grafted into porcine kidneys
Researchers developed a scalable, reproducible method to produce thousands of human kidney organoids and demonstrated integration of those organoids into perfused porcine kidneys ex vivo. The...
AI accelerates discovery…models and infrastructure scale up
Two developments point to AI’s expanding role in drug discovery: academic and industry groups released Boltz‑2, an AI model that predicts small‑molecule binding affinity at speed, and the Chan...
CAR‑T market jitters: sales slip even as axi‑cel shows clinical promise
Commercial dynamics for cell therapies are shifting: Gilead reported an 11% drop in cell‑therapy revenue for the quarter, citing lower demand for Yescarta and Tecartus, while a separate clinical...
Thermo Fisher to buy Clario for $8.88B – clinical data play
Thermo Fisher Scientific agreed to acquire Clario Holdings for $8.88 billion in cash to bolster its clinical data and endpoint capabilities. The deal—announced by Thermo Fisher—adds Clario’s...
FDA signals deregulatory push; biomarkers rise in agency agenda
FDA leadership signaled further deregulatory initiatives while CDER Director George Tidmarsh outlined agency efforts to reassess surrogate endpoints and expand biomarker use for accelerated...
HHS greenlights 340B rebate pilots — hospitals push back
HHS and HRSA approved multiple drugmaker proposals to test a 340B rebate model that shifts discounts to post‑dispense rebates rather than upfront discounts, prompting immediate objections from...
Nanoparticles deliver IL‑12 to tumors — MIT shows striking preclinical efficacy
MIT researchers engineered polymer‑coated nanoparticles that concentrate and release interleukin‑12 (IL‑12) within ovarian tumors, dramatically boosting responses to checkpoint inhibitors in mice....
Pfizer sues Novo Nordisk: Court fight erupts over Metsera takeover
Pfizer filed litigation in the Delaware Court of Chancery after Novo Nordisk launched a rival bid for Metsera, challenging the validity of Novo’s unsolicited offer and seeking to block Metsera...
FDA halts Intellia’s CRISPR trials: Regulator opens formal review after liver toxicity
The U.S. Food and Drug Administration placed formal clinical holds on two Phase 3 trials of Intellia Therapeutics’ CRISPR candidate nexiguran ziclumeran (nex‑z) following a grade‑4 liver adverse...
Scalable kidney organoids...porcine platform bridges supply and transplantation testing
Researchers reported a scalable method to produce thousands of uniform human kidney organoids and demonstrated their delivery and short‑term integration into perfused porcine kidneys during ex...
Nanoparticles deliver IL‑12: Local cytokine therapy clears metastatic ovarian tumors in mice
MIT and collaborators published preclinical data showing polymer‑coated nanoparticles that deliver IL‑12 into the tumor microenvironment markedly enhanced checkpoint inhibitor activity and...
Myeloid IFNγ signaling tied to ICI resistance in renal cancer
Researchers at Dana‑Farber Cancer Institute identified interferon‑gamma (IFNγ) signaling within tumor‑associated myeloid cells as a mechanism driving resistance to immune checkpoint inhibitors...
Gene therapy restores immune function in ADA‑SCID: Multi‑year follow‑up shows high cure rate
A joint UCL–UCLA team reported multi‑year follow‑up data in The New England Journal of Medicine showing a gene therapy for ADA‑SCID achieved approximately 95% success restoring immune function...
Google’s AI proposes validated cancer combo: Foundation model finds therapeutic leads
Google published results from a foundation model family (Cell2Sentence‑Scale/Gemma) that proposed and helped validate a new cancer drug combination, marking a milestone in AI‑driven biomedical...
From one‑off to pathway: Baby KJ team publishes FDA interactions to scale bespoke gene editing
Scientists behind the emergency CRISPR treatment for 'Baby KJ' published the FDA interactions and mapped a regulatory pathway for bespoke gene therapies, offering a template for academic and...