Changing the Pace of the FDA's Standard Review: Part Two

Cross-sectional comparative study of over 36,000 patients with diabetes found differences in the two groups, suggesting a need for broader patient criteria in trials.

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.

Data from part one of the Phase III RUBY trial show Jemperli (dostarlimab) plus chemotherapy produced a statistically significant and clinically meaningful survival benefit in patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient/microsatellite stable tumors.

In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.

Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.

In part 2 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses best practices for understanding specific therapeutic areas and deploying an effective eCOA strategy.