REMS Operational Challenges: Considerations in REMS Development and Long-term Management

Minimizing protocol deviations is a simple, yet effective way for sites to keep trials patient-centric.

Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.

Pfizer’s giroctocogene fitelparvovec reduced annualized bleeding rate in participants from week 12 up to at least 15 months and achieved superiority compared to prophylaxis.

In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.

The investigational prophylactic monoclonal antibody met its primary endpoints, reducing infections up to day-150.

Results from an induction trial and maintenance trial show Skyrizi (risankizumab) improved endoscopic and histological secondary outcomes characterized by endoscopic improvement, remission, and histological, endoscopic, and mucosal improvements in patients with moderately to severely active ulcerative colitis.