Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.
Another day, another two multibillion-dollar deals with Asian companies, this time involving Dizal Pharmaceutical Co. Ltd. and its EGFR inhibitor for lung cancer, as well as Innovent Biologics Inc. and its anti-CD40L antibody for a chronic fibroinflammatory condition.
Researchers from Stony Brook University Renaissance School of Medicine recently disclosed the design and development of a novel, multitargeted miRNA approach based on a gemcitabine-modified microRNA (miR)-129 mimic (Gem-miR-129) to overcome resistance to EGFR inhibitors.
As China becomes a major source of global clinical trial evidence, the retraction of a high-profile China-led lung cancer study is raising questions about whether journals, regulators and drug developers have adequate systems to validate fast-moving clinical claims.
Roche Holding AG’s Genentech unit achieved superior phase III results with its KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung (NSCLC) cancer patients.
As China becomes a major source of global clinical trial evidence, the retraction of a high-profile China-led lung cancer study is raising questions about whether journals, regulators and drug developers have adequate systems to validate fast-moving clinical claims.
As China becomes a major source of global clinical trial evidence, the retraction of a high-profile China-led lung cancer study is raising questions about whether journals, regulators and drug developers have adequate systems to validate fast-moving clinical claims.
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.
Missing statistical significance on the primary overall survival phase III endpoint with antibody-drug conjugate (ADC) sigvotatug vedotin compared with docetaxel in non-small-cell lung cancer (NSCLC), Pfizer Inc., which gained the candidate through its $43 billion buyout of Seagen Inc. in 2023, is forging ahead based on subgroup signals, phase I data and an ongoing phase III Keytruda combination effort currently underway.
