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Nature retracts timing-based PD-1 trial
Nature Medicine has retracted a randomized phase 3 study that claimed time-of-day dosing of PD-1 immunochemotherapy for non-small cell lung cancer improved outcomes, after an investigation found...
Pfizer ADC stumbles in Phase 3 NSCLC
Pfizer’s first ADC following its Seagen acquisition, sigvotatug vedotin (SV), failed to meet the primary overall survival endpoint in a Phase 3 trial in advanced, metastatic non-squamous NSCLC....
China clears first CAR T for solid tumors
China’s National Medical Products Administration (NMPA) approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid...
Ollin Biosciences raises $330M for Phase 3 Vabysmo challenger
Ollin Biosciences raised $330 million in a Series B to advance a Phase 3 program for its eye-disease therapy targeting both diabetic macular edema and wet age-related macular degeneration. The...
RQ Bio wins $115M for long-acting flu prevention antibody
RQ Bio secured $115 million in a Series A to advance RQB01, a long-acting antibody program aimed at seasonal influenza prevention. The London-based startup said the preclinical candidate is...
Lilly increases competition in undruggable targets via Antares deal
Novartis agreed to pay Antares Therapeutics $105 million upfront under a small-molecule discovery pact aimed at historically “undruggable” cancer targets. The collaboration is structured as a...
Sangamo’s bankruptcy triggers asset sales to Lilly and Astellas
Sangamo Therapeutics filed for Chapter 11 bankruptcy and lined up asset-sale agreements with Eli Lilly and Astellas as stalking horse bidders. The agreements cover Sangamo’s capsid delivery...
HHS rolls out blueprint to speed early drug development
The U.S. Department of Health and Human Services is moving to fast-track early-stage drug development with a new blueprint aimed at reducing the burden on biotech and improving access to clinical...
Carelon expands outpatient exome/genome testing coverage
Carelon updated its clinical appropriateness guidelines to include whole-exome sequencing (WES) and whole-genome sequencing (WGS) for certain outpatient scenarios, potentially shifting payor...
CAR T in solid tumors—China’s first approval
China’s National Medical Products Administration (NMPA) has approved Carsgen Therapeutics’ Claudin18.2-targeted, HER2-negative CAR T satricabtagene autoleucel (satri-cel/CT-041) for advanced...
AbbVie’s $10.9B immunology expansion via Apogee
AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion, adding late-stage IL-13 candidate zumilokibart (APG777) to its immunology pipeline. The deal values Apogee at $135.11 per...
Eye disease funding surge—Ollin’s $330M for Phase 3 Vabysmo challenger
Ollin Biosciences raised $330 million in a Series B as it prepares for Phase 3 trials of its Vabysmo challenger licensed from a China-based developer. The funding is designed to support pivotal...
Gene therapy regulatory reversal—Regenxbio resubmits for Hunter syndrome
Regenxbio said the FDA has reversed course on parts of its rejection of the company’s Hunter syndrome gene therapy Navsunli (RGX-121). After earlier concerns over eligibility criteria and the need...
Diagnostic approvals and clinical adoption—Natera MRD guidance in Japan and NCCN
Natera won Japan approval for its Signatera colorectal cancer MRD test in the neoadjuvant setting, backed by position statements from the Japan Society of Clinical Oncology and Japan Society of...
Genomic editing shake-up—Sangamo files for Chapter 11 and sells key platforms
Sangamo Therapeutics filed for Chapter 11 bankruptcy and moved to sell major parts of its technology portfolio. In asset-sale agreements, Eli Lilly is set to acquire Sangamo’s capsid delivery...
Waters and IMU team up on AI-driven immune profiling workflows
Waters and IMU Biosciences announced a strategic partnership to develop IMU’s AI-powered immune profiling platform using Waters’ flow cytometry and single-cell analysis technologies. The...
Big platform and lab automation deals—AI infrastructure meets execution
Medra launched AI Experimentalist, a reasoning layer for its physical AI drug discovery robotics platform, in a collaboration with DARPA. The system translates natural-language research goals into...
Insilico and SK Biopharmaceuticals expand AI CNS drug discovery deal
SK Biopharmaceuticals signed an AI-driven collaboration with Insilico Medicine valued at more than $2.5 billion to accelerate neuroimmune disorder drug discovery in the CNS. The milestone-heavy...
Clinical trial failure—Cynata’s Cymerus misses endpoints
Cynata Therapeutics said neither of its pivotal Cymerus stem cell platform trials met primary endpoints in osteoarthritis and graft-versus-host disease (GVHD). CEO Kilian Kelly told investors the...
Large pharma dealmaking: Lilly expands discovery pact with Abbisko
Eli Lilly has signed a new drug discovery collaboration with Abbisko Therapeutics, building on an earlier pact from 2022, with potential payments to Abbisko of up to $1.9 billion. The companies’...