The U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding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.
Pfizer Inc. and Bayer said on March 14 they would maintain humanitarian supply of medicines to Russia, but would pull back from other non-essential spending in the country.
Merck announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL) – a nucleoside reverse transcriptase translocation inhibitor – for pre-exposure prophylaxis (PrEP) in people at high risk of HIV-1 infection.
The U.S. Food and Drug Administration placed a clinical hold on Boston-based Aprea Therapeutics’ lymphoid malignancy trial after the regulatory agency expressed concerns regarding the safety and efficacy data from a previous myelodysplastic syndromes (MDS) study.
CVS Health announced a new Clinical Trial Services business that brings together innovation and experience, driving greater access to clinical trials across the communities the company serves and creating a more efficient, convenient experience to improve participant retention and research effectiveness.
Regeneron Pharmaceuticals said on May 17 the company was resuming the enrollment of patients in two studies testing the experimental lymphoma drug odronextamab after the U.S. Food and Drug Administration agreed to lift a partial clinical hold.
Large vaccine trials that are extensive both in size and scope tax the resources of sponsors and contract research organizations (CROs), particularly when the trials seek to compress a process that ordinarily takes years. Rapid but safe implementation of these vaccine studies’ new protocols is pushing trial design to the limit.
REGENXBIO Inc. provided an update on the RGX-314 programs, including the announcement that the pivotal program for RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) is active.
Johnson & Johnson enrolled about 45,000 participants for the first late-stage trial of the company’s Covid-19 single-dose vaccine candidate, with interim data expected by late January.
Regeneron Pharmaceuticals Inc. paused patient enrollment in two clinical studies testing the company’s experimental lymphoma drug, after the U.S. health regulator requested changes in trial protocols.