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FDA backs Gilead’s Trodelvy for first-line triple-negative breast cancer
The FDA approved Gilead’s Trodelvy for first-line treatment of triple-negative breast cancer (TNBC), adding a second authorization for Trodelvy shortly after the agency cleared a rival breast...
China clears first CAR T for solid tumors
China’s National Medical Products Administration approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global authorization for a CAR T therapy in solid...
Antares and Novartis strike $1.9B pact for undruggable cancer targets
Novartis will collaborate with Antares Therapeutics on small-molecule discovery against oncology targets considered “undruggable,” in a deal valued up to $1.9 billion with a $105 million upfront...
AbbVie to acquire Apogee Therapeutics in $10.9B immunology deal
AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion, adding zumilokibart (APG777), a long-acting, subcutaneous IL-13–targeting monoclonal antibody, to AbbVie’s immunology...
Sangamo files for Chapter 11 as Lilly and Astellas line up for key assets
Sangamo Therapeutics filed for Chapter 11 bankruptcy and agreed to asset sale terms with Eli Lilly and Astellas as “stalking horse” bidders, seeking to monetize major parts of its platform. The...
Eli Lilly invests $50M led by Absci AI startup for hair growth and beyond
Absci announced a $50 million funding round led by Eli Lilly, with Lilly investing $40 million for equity in the Nasdaq-listed startup. Absci’s program focus includes developing a medication...
RQ Bio raises $115M Series A for long-acting, broad flu prevention antibody
RQ Bio secured a $115 million Series A to advance RQB01, a preclinical, long-acting antibody program aimed at preventing seasonal influenza with broad protection. The company said the candidate...
UCI Health begins first-in-human embryonic stem-cell neural stem cell trial for Huntington’s
UCI Health launched a Phase Ib/IIa clinical trial evaluating hNSC-01, an embryonic stem cell-derived neural stem cell therapy for Huntington’s disease. The trial uses neural stem cells delivered...
Nature retracts LungTIME-C01 timing-of-immunotherapy phase 3 findings
Nature Medicine retracted a randomized phase 3 study claiming time-of-day immunochemotherapy improves outcomes in non-small cell lung cancer, citing multiple problems and lack of editorial...
ADC Therapeutics reorganizes amid Zynlonta safety concerns
ADC Therapeutics is cutting about 17% of staff as it focuses resources behind Zynlonta after safety concerns surfaced in a confirmatory study, the company said in a June 24 release. The Swiss ADC...
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...