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Lilly Plumbs Data's Depths To Differentiate CDK4/6 Inhibitor Verzenio

 
• By Mandy Jackson

Lilly highlighted five prognostic factors at SABCS that may be linked to high Verzenio response. As the third CDK4/6 inhibitor on the US market, the company needs to differentiate its breast cancer drug from Pfizer's Ibrance and Novartis's Kisqali.

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A new analysis of two Phase III studies for Eli Lilly & Co.'s Verzenio (abemaciclib) in advanced breast cancer confirmed that five factors associated with patients' status had prognostic relevance, which could help the company differentiate its third-to-market drug.

The exploratory analysis of the MONARCH 2 and MONARCH 3 clinical trials in hormone receptor-positive (HR+)/human epidermal growth factor receptor...

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In Brief: Atai-Beckley Deal Marches On After Phase II Psychedelic Win

 
• By Manas Mishra

The psychedelic therapy firms pass a key condition for their planned merger after the antidepressant BPL-003 meets the main endpoints of a Phase IIb trial.

BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
• By Kevin Grogan

The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 
• By Sushmita Panda

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

BlissBio Goes Solo On HER2-Targeting ADC After Eisai Exit

 
• By Dexter Jie Yan

BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.

More from R&D

BlissBio Goes Solo On HER2-Targeting ADC After Eisai Exit

 
• By Dexter Jie Yan

BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.

Watch This Space: Miltenyi‘s ‘Brain-To-Vein,’ Point-Of-Care CAR-T Efforts In India

 
• By Anju Ghangurde

From a letter of intent with BIRAC sealed at BIO 2025 to supporting Immuneel’s CAR-T efforts and a study for point-of-care manufactured anti-CD19 CAR-T cell therapy, Miltenyi Biotec is moving on multiple fronts in India. The German group also expects to advance its own CAR-T candidates.

Decentralized Trials Enroll Larger, More Diverse Patient Populations

 
• By Alaric DeArment

A new study by Tufts CSDD performed a deep dive into use of decentralized clinical trial techniques, but one of the study’s authors said DCTs have been dialed back.