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Public Citizen has petitioned the FDA to require a black box warning for sodium-glucose cotransporter-2 (SGLT2) inhibitors used off-label for treatment of type 1 diabetes. Read More
New York-based BrainStorm Cell Therapeutics is launching a phase 2 trial of an investigational stem cell treatment for Alzheimer’s disease, using cells derived from patients’ bone marrow. Read More
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