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Repeated COVID-19 boosters simply aren’t a practical way to deal with the shape-shifting SARS-CoV-2 virus, according to members of the FDA’s Vaccines and Related Biologics Advisory Committee. Read More
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 intakes. Read More
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. Read More
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The FDA has withdrawn its Emergency Use Authorization (EUA) for the GlaxoSmithKline and Vir Biotechnology COVID-19 monoclonal antibody treatment sotrovimab based on data indicating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