The U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding on the agency’s previous guidances for industry to improve clinical trial diversity.
While the Centers for Medicare & Medicaid Services undergoes the comment period on its national coverage decision for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), Biogen and its partner company Eisai released additional details about the Phase IV post-marketing study of the drug.
Drug developer Novavax Inc. completed enrolling 30,000 volunteers in a late-stage study of the company’s Covid-19 vaccine in the United States and Mexico.
Many Americans are hesitant to be vaccinated against Covid-19, according to research from Invisibly.
Abbott became the first anchor sponsor of the American Diabetes Association’s Health Equity Now platform to address health disparities for people with diabetes.
Moderna Inc. said an analysis of the early-stage data of the company’s experimental Covid-19 vaccine showed mRNA-1273 induced immune responses in older adults that were similar to younger participants.