ACT 2015 Rates

Decision follows underwhelming Phase II results from GALAXIES Lung-201 and H&N-202 trials, prompting iTeos and GSK to end development of the TIGIT-targeting antibody and halt enrollment in all ongoing belrestotug studies.

In 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.

The REAL8 basket study showed Sogroya (somapacitan) was non-inferior to Norditropin (somatropin) in improving yearly growth rate.

Overcoming hurdles with licensing complexities, post-production changes, and IRB submissions can help in reducing timelines and increasing collaboration.

In the first head-to-head comparison of leading incretin-based therapies, Eli Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide (Zepbound) delivered significantly greater and sustained weight loss than semaglutide (Wegovy) over 72 weeks in adults with obesity or overweight and comorbidities.