In January, Germany's cost watchdog decided that Dendreon's--now Valeant's--Provenge had no added benefit for men with metastatic prostate cancer. But now, it's changing its tune.
It's more bad news for Eli Lilly's Alimta in Europe. After losing a patent fight last year with Actavis in England, the Indianapolis drugmaker has now lost another in Germany, paving the way for knockoff versions of its top drug there.
U.S. drugmaker Mylan, Germany's Stada, India's Dr. Reddy's Laboratories and Unichem Laboratories are among 16 drugmakers who have had dozens of generic meds sidelined by German regulators who raised questions about bioequivalence tests.
Six years after the FDA banned products from a Ranbaxy Laboratories plant in Dewas, India, the European Commission and Germany have restricted imports of sterile drugs from the facility.
Seemingly hand in hand with the U.S., German regulators have banned Ranbaxy Laboratories from exporting the antibiotic cephalosporin to their country following an inspection earlier this year of the company's plant in central India.
Germany's cost-effectiveness gatekeepers have delivered another blow to Eisai over the price of Fycompa. And the verdict, just the drugmaker's latest frustration over the epilepsy drug, has left it "speechless" and "dismayed."
After tainted Chinese heparin in 2008 led to dozens of deaths of dialysis patients in the U.S., global regulators started touting the need for heparin makers to be able to track back sources to ensure they were safe. German meat company T ö nnies saw an opportunity there, bought a German heparin API maker and started building a brand-new plant. That facility was dedicated this week and will start producing heparin intermediates this year.
Germany's Aenova has been in expansion mode. It pumped up production capacity with its acquisition last year of contract manufacturer Haupt Pharma and has now bought a U.S. company to help it boost its packaging capabilities.
Biogen Idec's multiple sclerosis blockbuster Tecfidera for a second time has hit a roadblock in its effort to replicate in Europe the kind of runaway success it has had in the U.S. Germany's price watchdog IQWIG says it has found "no additional benefit" for the treatment compared to existing options, a preliminary decision that could deny it premium pricing there.
Germany is implementing a system that allows the authenticity of drugs to be checked at the pharmacy level to protect against counterfeits.