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The UK’s health cost-benefit watchdog refused to recommend Roche’s Kadcyla as a treatment for HER2-positive breast cancer, saying the $151,000 per patient cost is out of reach for the National Health Service. Read More
The FDA hopes to soon wrap up the 45-plus year process of clearing from the market older drug products that were never proven effective before being sold. Read More
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
The FDA has produced final recommendations for how manufacturers can prove “sameness” when they develop generic versions of monoclonal antibody (mAb) products approved under the Orphan Drug Program. Read More
The FDA Monday approved Eli Lilly’s Cyramza to treat advanced gastric cancer — a shot in the arm for Lilly, which is attempting to recover from expiring patents on two blockbuster products. Read More
Emergent BioSolutions has received an orphan drug designation for an expanded indication for BioThrax, its anthrax vaccine already in wide use by the U.S. military. Read More
U.S. Supreme Court Chief Justice John Roberts on Friday denied Teva’s attempt to recall and stay a lower court’s ruling that invalidated a patent on Copaxone, opening the gate for generic versions of the blockbuster multiple sclerosis drug to reach the market as early as next month. Read More
The FDA has approved GlaxoSmithKline and Genmab’s Arzerra and Leukeran as a first-line combination treatment for the most common form of blood and bone marrow cancer. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More