The U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding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.
The European Medicines Agency on March 25 recommended the use of Johnson & Johnson and partner Legend Biotech Corp.’s CAR-T therapy Carvykti to treat multiple myeloma, nearly a month after the treatment was cleared in the United States.
To address a lack of diversity, California-based Medable and CVS have forged a collaboration to improve patient access to clinical trial research.
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.
Fully integrated biopharmaceutical solutions organization Syneos Health announced the acquisition of StudyKIK, a leading technology-enabled clinical trial recruitment and retention company.
Compas on July 27 announced a rebranding that reflects future growth of the organization and expansion of its capabilities.
Medable Inc., a leading cloud platform for patient-centered drug development, announced the hiring of Sanskriti Thakur as chief growth officer.
The Covid-19 epidemic highlighted the disproportionate way the virus impacted minority communities across the U.S., increasing the calls for racial and ethnic diversity in clinical studies. While there has been a more significant push, a recent Pfizer clinical trials diversity report shows there is still a wide gap that needs to be bridged.
Acting FDA Commissioner Janet Woodcock shared her thoughts on pandemic issues and outlined FDA modernization plans in a Q&A session with the Alliance for a Stronger FDA..
closerlook inc. is alerting Black creatives about a free, 16-week portfolio program established by nonprofit One Club for Creativity known as ONE School.