Authorities Recognize a Need to Encourage Pediatric Drug Development

A pragmatic approach to streamlining technology and innovating processes will help advance clinical data management.

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.

Improving access while maintaining a high level of research.

Welireg (belzutifan), an oral HIF-2α inhibitor, demonstrated an objective response rate of 26% in the LITESPARK-015 study.

In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.