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A 2017 California law banning the use of co-payment coupons for brand-name drugs with direct generic competitors was associated with no significant increase in generic substitution in its first year. Read More
GlaxoSmithKline (GSK) and Vir Biotechnology have reported that final results from their phase 3 study on sotrovimab show that the monoclonal antibody — which was granted Emergency Use Authorization (EUA) by the FDA on May 27 — significantly reduces hospitalization and risk of death in adults with mild-to-moderate COVID-19 who are at high risk of progression to severe disease. Read More
Horizon Therapeutics has entered into a $700 million development and licensing deal with Arrowhead Pharmaceuticals for Arrowhead’s investigational RNA interference (RNAi) treatment for gout. Read More
All post-approval changes to a Biologics License Application (BLA) should be submitted based on three categories organized by risks to safety and efficacy, the FDA said in a final guidance released yesterday. Read More
Gilead Sciences has said its antiviral Veklury (remdesivir) reduced hospitalization and death rates for COVID-19 patients, based on new results from three real-world studies. Read More
The EU has approved Sanofi’s Aubagio (teriflunomide) for use in children and adolescents with multiple sclerosis — just days after the FDA issued the company a Complete Response Letter regarding its supplemental New Drug Application (sNDA) for Aubagio, rejecting its use in children and adolescents ages 10 to 17 years and requesting more pediatric data. Read More
