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The proprietary therapy “has the potential to significantly advance the treatment of gliomas,” says Vijay Agarwal, the company’s founder and CEO, who is a practicing brain tumor surgeon. Read More
Novo Nordisk is going after Biocon Pharma, claiming patent infringement over a generic version of Novo’s weight loss drug Saxenda (liraglutide injection), a glucagon-like peptide-1 (GLP-1) receptor agonist. Read More
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
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
The FDA’s review of proposed instructions for use (IFU) for a new drug, biologic or combination product will focus on accuracy and consistency with the agency-approved prescribing information, according to a final labeling guidance issued yesterday. Read More