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Proposed Senate legislation to cap the cost of insulin would cost the federal government in excess of $23 billion over the next 10 years — more than twice as much as the similar House version, according to a new analysis from the Congressional Budget Office (CBO). Read More
Precision Nuclear of Virginia landed a Form 483 following a March 22 to 25 inspection of its positron emission tomography (PET) drug facility in Roanoke, Va., where FDA officials observed multiple quality lapses. Read More
Novo Nordisk’s Wegovy (semaglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist, shows better efficacy for weight loss than its peers but it requires a significant discount to be cost-effective, according to a new analysis from the Institute for Clinical and Economic Review (ICER). Read More
With the clock ticking loudly on must-pass user fee reauthorization, Senate Committee on Health, Education, Labor and Pensions (HELP) ranking member Richard Burr (R-N.C.) — a month after his committee advanced bipartisan user fee legislation to the Senate floor — has introduced an alternative user fee bill that strips out all riders and amendments on which the HELP committee had worked for months. Read More
Teva Pharmaceuticals has petitioned the U.S. Supreme Court to review federal appeals court rulings ordering that the drugmaker pay $235.5 million in damages to GlaxoSmithKline (GSK) for patent infringement of GSK’s congestive heart failure drug Coreg (carvedilol). Read More
The FDA has deferred action on BeiGene’s Biologics License Application (BLA) for the monoclonal antibody tislelizumab for esophageal cancer, saying the agency has been unable to conduct required inspections in China due to COVID-19-related travel restrictions. Read More