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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
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 esophagus associated with acid reflux, gastrointestinal problems, difficulty eating and failure to thrive. 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
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 lowers antithrombin. Read More