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…
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…
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…
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…
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…
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…
Sanofi and Regeneron’s Dupixent (dupilumab) continues its march against a host of chronic inflammatory diseases, posting positive phase 3 data in children with eosinophilic esophagitis, a chronic inflammation of the…
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…
Merck and the Orion Corporation have struck a $290 million deal to develop a line of drugs that could help treat prostate cancer. Source: Drug Industry Daily
More encouraging news about potential hemophilia therapeutics emerged this week, with Sanofi announcing “unprecedented” phase 3 data on efanesoctocog alfa, a bioengineered clotting factor, and fitusiran, an RNA therapeutic that…