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Regulatory clearance and new diagnostics automation
Roche won FDA clearance for two Cobas Pro lab automation units and secured CE marking for a blood donor screening assay, expanding its push to boost high-throughput testing with modular platforms....
AI drug discovery expansion and commercialization licensing
Eli Lilly agreed to pay Insilico Medicine $115 million upfront and structured the deal for up to about $2.75 billion in additional payments tied to development, regulatory and commercial...
Phase 3 eczema competitive readout
Connect Biopharma reported multi-endpoint improvements in a Phase 3 eczema trial and said its dupilumab-like competitor achieved 52-week gains, supporting the company’s view that its approach can...
Phase 3 thyroid eye disease rival to Tepezza
Viridian Therapeutics reported a Phase 3 win for elegrobart, an anti-IGF-1R antibody in thyroid eye disease, and said the program hit its primary endpoint in REVEAL-1. The study enrolled 132...
Gene therapy commercialization milestone
Rocket Pharmaceuticals received FDA approval for Kresladi, positioning the therapy as the first commercial gene therapy for leukocyte-adhesion deficiency type 1, an ultra-rare inherited...
FDA/clinical trial readouts and pipeline reshaping in obesity
Wave Life Sciences shares dropped sharply after the company reported mixed early clinical data for WVE-007, its RNA-based obesity candidate, in the Phase I INLIGHT trial. Investors focused on...
Corporate science event tied to obesity/heart failure dosing strategy
At ACC26, Merck signaled it is leaning toward a lower Winrevair dose for a pivotal Phase 3 program after seeing what it called a “pretty profound” benefit at the lowest dose in a prior Phase 2...
Biologic pipeline progress in autoimmune lupus
Biogen reported additional Phase 2 lupus results for litifilimab, describing improvements in skin lesions that strengthen momentum toward potentially pivotal readouts. The company said the therapy...
Clinical molecular diagnostics automation workflow partnerships
Takara Bio USA and Hamilton announced a partnership to develop and co-market automated NGS library prep workflows using Hamilton’s Microlab Star platform. The companies plan to automate Takara’s...
Microbiome test access via consumer platform partnership
Everlywell and Jona teamed up to expand consumer access to a gut microbiome test through Everlywell’s digital health platform. The partnership aims to increase reach for Jona’s microbiome offering...
Regulatory milestone
Rocket Pharmaceuticals has won FDA approval for Kresladi, a gene therapy for leukocyte-adhesion deficiency type 1 (LAD-1), an inherited immunodeficiency that can be fatal in early childhood. The...
Phase 2 efficacy signal meets mechanistic endpoint
Kardigan reported mixed Phase 2 results for tonlamarsen (licensed from Ionis Pharmaceuticals) in uncontrolled hypertension: the antisense oligonucleotide reduced angiotensinogen (AGT) by Week 20,...
Obesity drug early data disappoints investors
Wave Life Sciences’ Wave-007 update triggered a sharp selloff after the company reported mixed early-stage obesity data in its Phase I INLIGHT trial. Investors focused on a less than 1%...
Autoimmune pipeline momentum
Biogen’s litifilimab gained traction with new Phase 2 lupus readouts, with the company reporting improvements in another trial and building toward potential pivotal data. The latest results add to...
Clinical trial dose strategy tweak for late-stage heart failure program
Merck said it is leaning toward a lower Winrevair dose in a pivotal Phase 3 trial for a rare form of heart failure after observing a “pretty profound” benefit at the lowest dose in its earlier...
AI for clinical operations oversight
Revvity Signals described how AI is being used to manage the growing review burden in late-stage clinical development, arguing that automation is becoming necessary as Phase III trials generate...
AI drug discovery commercialization deal
Insilico Medicine and Eli Lilly inked a commercialization agreement for some of Insilico’s preclinical AI-discovered oral therapeutics, with economics tied to regulatory and commercial milestones....
Startup-backed gene therapy expansion
Kailera Therapeutics, which has raised one of the largest rounds of 2025, is planning an IPO to fund advancement of its obesity pipeline through the clinic. The planned public offering comes as...
Blood-cancer research collaboration
The Josep Carreras Leukaemia Research Institute and China’s Institute of Hematology & Blood Diseases Hospital (IHCAMS) under the Chinese Academy of Medical Sciences and Peking Union Medical...
Cell therapy-grade protein delivery concept (preclinical/innovation)
Researchers at the University of Manchester won nearly £1 million from UK Research and Innovation to build snail-inspired soft microrobots for precision anti-cancer drug delivery in bowel cancer....