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EU biopharma groups have lodged a complaint with the European Commission opposing a French law that promotes off-label use of medicines, saying it puts cost ahead of patient safety. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the U.S. Food and Drug Administration, saying draft guidance lacks clear criteria and examples. Read More
The FDA has granted breakthrough therapy designation to Roche’s investigational ACE910 for the prophylactic treatment of patients 12 years and older with hemophilia A with factor VIII inhibitors. Read More
With the last legal hurdle removed, Sandoz wasted no time launching its Zarxio biosimilar of Amgen’s chemotherapy product Neupogen nationwide — offering the first U.S. biosimilar at 15 percent below the price of its reference product. Read More
Sanofi will terminate its 19-month collaboration with Ardelyx, effective Sept. 30, ending an alliance that focused on developing NaP2b phosphate inhibitors for kidney disease. Read More
Sanofi will terminate its 19-month collaboration with Ardelyx, effective Sept. 30, ending an alliance that focused on developing NaP2b phosphate inhibitors for kidney disease. Read More
Amgen and Novartis have launched a neuroscience drug collaboration to develop and commercialize new inhibitors to fight Alzheimer’s disease and treat migraines. Read More