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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...
Multi‑cancer screening gains traction: Real‑world data and commercial launches collide
A Nature Communications analysis of more than 100,000 multi‑cancer detection tests released real‑world insights into sensitivity, tissue‑of‑origin signals, and clinical utility across cancer...
COVID mRNA vaccines...tumor response link: Retrospective data suggest improved immunotherapy outcomes
MD Anderson researchers presented retrospective clinical analyses and mouse data showing that patients who received COVID‑19 mRNA vaccination before starting checkpoint inhibitor therapy lived...
Bidding war erupts for Metsera: Pfizer sues as Novo tops offer
Pfizer has initiated litigation to block Novo Nordisk’s unsolicited takeover bid for Metsera, after Novo publicly offered a higher, two‑step proposal. Pfizer alleges Novo’s structure is designed...
FDA places formal hold on Intellia’s CRISPR trials: liver events prompt pause
The U.S. Food and Drug Administration has placed a formal clinical hold on two Phase 3 studies of Intellia Therapeutics’ in vivo CRISPR candidate nexiguran ziclumeran (nex‑z) after a serious...
AI accelerates drug discovery... Google and Foundation roll out new tools
Google announced an AI model that proposed and validated a novel cancer drug combination, marking a high‑visibility step for large‑scale foundation models applied to small‑molecule and combination...
4DMT sells retina gene therapy to Otsuka – upfront cash to fund phase 3
4D Molecular Therapeutics struck a deal with Otsuka Pharmaceutical granting Asia‑Pacific rights to its retinal gene therapy 4D‑150, securing $85 million upfront and potential development...
Evommune files IPO: $150M target to advance two mid‑stage programs
Evommune, an inflammation‑focused biotech, filed to go public targeting roughly $150 million to advance two Phase 2 programs: EVO756, an oral MRGPRX2 antagonist, and EVO301, an IL‑18 neutralizing...
Nanobiotix gets royalty loan; Tubulis upsizes Series C to $401M
Nanobiotix secured $71 million in non‑dilutive financing from HealthCare Royalty to support the late‑stage development of its radiotherapy‑activated nanotherapy partnered with Johnson & Johnson....
Lilly’s tirzepatide soars — Novo’s new CEO doubles down on M&A
Eli Lilly reported tirzepatide (Mounjaro/Zepbound) sales exceeding $10 billion for the third quarter, prompting the company to raise revenue guidance. The blockbuster performance cements...
Human kidney organoids integrated with pig kidneys... scalable transplant step
Researchers demonstrated a scalable pipeline to produce thousands of human kidney organoids and integrate them into ex vivo perfused porcine kidneys, then perform the first transplants of porcine...