Two draft guidelines from the International Council for Harmonization (ICH) were released yesterday for public comment, one on pediatric extrapolation in clinical trials and the other on calculating compound-specific acceptable…
The FDA issued a final guidance yesterday for sponsors of drugs and biologics for the treatment of chronic hepatitis B that expands upon a November 2018 draft. Source: Drug Industry…
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…
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). Source: Drug Industry Daily
To expand the field of gene therapy, Peter Marks, director of the FDA’s Center for Biologics Evaluation (CBER), believes that the current clinical development framework is in need of rethinking…
The FDA has withdrawn its Emergency Use Authorization (EUA) for the GlaxoSmithKline and Vir Biotechnology COVID-19 monoclonal antibody treatment sotrovimab based on data indicating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…
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. Source: Drug…
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…
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…
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. Source: Drug Industry Daily