January 2017

The European Commission has approved an update to the Jardiance® (empagliflozin) label to include a change to the indication statement. Jardiance® is now indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2D) as an adjunct to diet and exercise.The approved product information now includes data on the reduction of risk of cardiovascular (CV) death in patients with T2D and established CV disease in addition to data on the improvement of blood sugar control.Jardiance® is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date. Jardiance® is marketed by Boehringer Ingelheim and Eli Lilly and Company (LLY).

VBX Stent Graft has received U.S. Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. This marks the availability of the only balloon expandable stent graft with an indication for the iliac artery.

U.S. District Court of Delaware ruling invalidating all asserted claims of the ‘250, ‘413, ‘776 and ‘302 patents for COPAXONE® (glatiramer acetate injection) 40 mg/mL by TEVA. The patent infringement case involved five of six Abbreviated New Drug Application (ANDA) filers. Teva plans to appeal the decision.