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Senior Democrats in the House unveiled a bill yesterday that would give HHS the authority to negotiate prices for hundreds of drugs and would tax noncompliant drugmakers up to 95 percent of their sales. Read More
Fulcrum Therapeutics has begun a phase 3 clinical trial in the U.S. of its investigational anti-inflammatory drug losmapimod for the treatment of hospitalized COVID-19 patients. Read More
Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or efficacy. Read More
Sanofi has progressed faster than anticipated with a COVID-19 vaccine candidate being developed in collaboration with GlaxoSmithKline (GSK), according to the company’s CEO. Read More
FibroGen has initiated a phase 2 trial of its monoclonal antibody pamrevlumab for the treatment of hospitalized patients with acute COVID-19 infections. Read More
Three high-ranking House Democrats have asked FDA Commissioner Stephen Hahn for more details of the agency’s review process for COVID-19 vaccines. Read More
FDA Commissioner Stephen Hahn assured House lawmakers yesterday that the agency will maintain its regulatory independence in reviewing COVID-19 vaccine candidates, staying at arm’s length from the Trump administration’s Operation Warp Speed, which aims to have an effective vaccine by year’s end. Read More