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Lundbeck’s Vyepti (eptinezumab-jjmr), a monoclonal antibody approved for the treatment of migraines, was associated with greater declines in headache frequency and days of acute headache medication use vs. placebo in people dually diagnosed with chronic migraine and medication overuse headache, the company said. Read More
Citius Pharmaceuticals claimed a topline win in its pivotal phase 3 trial of I/Ontak (E7777) in patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). Read More
To expand the field of gene therapy, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), believes that the current clinical development framework is in need of rethinking in terms of trial design, endpoints, communication and other areas. Read More
The FDA has withdrawn its Emergency Use Authorization (EUA) for the GlaxoSmithKline and Vir Biotechnology COVID-19 monoclonal antibody treatment sotrovimab based on data indicating that it isn’t effective against the Omicron BA.2 subvariant. Read More
In one of his first public presentations as FDA commissioner, Robert Califf outlined his vision for enhanced use of health data as the way to improve health outcomes. Read More
The Office of Inspector General (OIG) within the Department of Health and Human Services has called for the increased use of biosimilars to reduce spending by the federal government’s Medicare Part D prescription drug program. Read More
Bayer’s Kerendia (finerenone) reduced the risk of cardiovascular and kidney disease events in patients with type 2 diabetes and chronic kidney disease, being especially effective in those with atherosclerotic cardiovascular disease (ASCVD). Read More
Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will attempt to grapple with the problem of SARS-CoV-2’s vexing ability to escape vaccine coverage. Read More