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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...
Nanoparticle IL‑12 therapy revives ovarian immunotherapy responses
MIT teams published preclinical data showing polymer‑coated nanoparticles that deliver IL‑12 directly to ovarian tumors can convert immunologically cold lesions into responsive ones and, when...
Gene therapy milestone for ADA‑SCID... Baby KJ roadmap published
A joint UCL–UCLA gene therapy program reported multi‑year follow‑up data showing a gene therapy for ADA‑SCID restored immune function in treated children with a 95% success rate and no major...
Metsera takeover fight: Novo tops Pfizer with higher bid, legal clash ensues
Novo Nordisk submitted a higher unsolicited offer for obesity biotech Metsera, prompting an immediate legal and strategic response from Pfizer. Novo’s bid raises the deal value well above Pfizer’s...
Intellia CRISPR trials halted: FDA places formal hold after liver toxicity case
The FDA placed a clinical hold on two Phase 3 trials of Intellia Therapeutics’ CRISPR candidate nexiguran ziclumeran after a participant experienced severe liver enzyme elevations and...
Human kidney organoids scaled and integrated into pig kidneys...first in‑vivo transplant milestone
Researchers developed a scalable method to produce thousands of human kidney organoids and demonstrated integration with perfused porcine kidneys ex vivo, culminating in the first transplant of...
AI accelerates drug discovery and cell modeling: Google proposes a cancer drug; CZI and NVIDIA scale virtual cells
Google unveiled an AI-led discovery claiming a validated new cancer drug combination generated by its Cell2Sentence-Scale model family, signaling rapid advances in foundation models applied to...
Heritable genome editing and bespoke CRISPR: startups form and clinicians publish FDA playbook
A wave of ventures pursuing heritable genome editing emerged, with one U.S. entrepreneur raising significant early funding to study the ethics and feasibility of gene-edited embryos. At the same...
Tumor resistance mechanisms: Myeloid IFNγ signaling and copy-number changes undermine immunotherapy
Dana-Farber researchers identified interferon‑gamma signaling within tumor-associated myeloid cells as a driver of resistance to immune checkpoint inhibitors in renal cell carcinoma, revealing a...
Localized cytokine delivery: IL‑12 nanoparticles revive ovarian tumor immunity in preclinical models
MIT and collaborators engineered polymer-coated nanoparticles that deliver IL‑12 directly to ovarian tumors and demonstrated robust antitumor responses when combined with checkpoint inhibitors. In...