Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said the European Commission approved Jardiance 10-mg and 25-mg once-daily tablets for use when diet and exercise alone do not provide adequate glycemic control. Jardiance, a sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes mellitus, may be used alone when metformin is not considered appropriate due to intolerance or alongside other glucose-lowering medicines, including insulin, when glucose control is inadequate.

Roche AG, of Basel, Switzerland, said the EMA's Committee for Medicinal Products for Human Use recommended approval of Gazyvaro (obinutuzumab) in combination with chlorambucil for use in adults with previously untreated chronic lymphocytic leukemia who have co-morbidities making them unsuitable for fludarabine. Gazyvaro, a monoclonal antibody designed to attach to CD20, is marketed as Gazyva in the U.S. and the rest of the world. (See BioWorld Today, Nov. 4, 2013.)

Takeda Pharmaceuticals U.S.A. Inc., of Deerfield, Ill., part of Takeda Pharmaceutical Co. Ltd., won a case related to Actos (pioglitazone) for type 2 diabetes in Nevada state court. The verdict marks the fifth win for Takeda out of six Actos trials, and Takeda is challenging the ruling in the sixth case. Takeda was accused of hiding bladder-cancer risks related to the compound.

Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA approved the use of Qvar (beclomethasone dipropionate) with a dose counter for the ongoing treatment of asthma as a preventative therapy in patients, ages 5 and older. The new inhaled corticosteroid product is expected to be available commercially later this year.