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Merck announced yesterday that it is discontinuing its phase 3 nonsmall-cell lung cancer trial of Keytruda (pembrolizumab) in combination with Bristol Myers Squibb’s (BMS) Yervoy (ipilimumab), citing an unfavorable benefit-risk profile. Read More
Canadian biopharmaceutical company Medicago has announced that its investigational COVID-19 vaccine generated “significant antibody and cellular immune responses” after two doses in all subjects in an early-stage clinical trial. Read More
Brazil’s National Agency for Sanitary Surveillance (ANVISA) has suspended Beijing, China-based Sinovac’s phase 3 trial of its COVID-19 vaccine, CoronaVac, halting the study Tuesday to evaluate a serious adverse event that occurred. Read More
Almost two-thirds of participants in clinical trials to support U.S. drug approvals from 2015 to 2019 were outside the U.S., the FDA’s Center for Drug Evaluation and Research (CDER) said in a new report unveiled yesterday. Read More
As part of its ongoing efforts to make clinical trials more representative of the population, the FDA yesterday issued a final guidance on what sponsors should do to make trials more accessible and appealing to under-represented racial, ethnic, gender and age groups. Read More
The FDA has issued an Emergency Use Authorization (EUA) for Eli Lilly’s monoclonal antibody treatment bamlanivimab (LY-CoV555), clearing the drug for use in high-risk patients with mild-to-moderate COVID-19 who don’t need hospitalization or oxygen. Read More
The UK’s National Institute for Health and Care Excellence (NICE) is considering changes to how it evaluates the cost-effectiveness of medicines and is inviting public comment. Read More
The European Commission has approved AstraZeneca’s leukemia drug Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL). Read More
Rick Bright, who was leading the vaccine effort at NIH’s Biomedical Advanced Research and Development Authority (BARDA) but was pushed aside by the Trump administration, has joined President-Elect Joe Biden’s Transition COVID-19 Advisory Board. Read More