Quotient Clinical has announced results from an Enabled-First-in-Human (Enabled-FIH) program conducted for the Janssen WAVE Early Development unit.
Quotient Clinical has announced results from an Enabled-First-in-Human (Enabled-FIH) program conducted for the Janssen WAVE Early Development unit. The integrated pharmaceutical development and first-in-human clinical program was designed to develop an optimal oral formulation, in parallel with the assessment of single and multiple dose safety, pharmacokinetics and pharmacodynamics of a highly selective small molecule c-Met tyrosine kinase inhibitor. The clinical phase, which was conducted under a single, adaptive protocol, was completed in only six months.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.