Business & Industry News Channel
Novartis announced that the European Commission (EC) has approved Onbrez Breezhaler (QAB149 or indacaterol) in both 150 mcg and 300 mcg doses as a new once-daily maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
The "Deutscher Zukunftspreis 2009" of the German President has been awarded to an R & D team from Bayer: Dr. Frank Misselwitz, Dr. Elisabeth Perzborn and Dr. Dagmar Kubitza received the prize for achievements in technology and innovation from the German Federal President Horst Köhler in Berlin. The Bayer scientists from Wuppertal were honored with the prestigious award for the development of the new anticoagulant drug rivaroxaban (Xarelto®). 
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the European Commission has granted marketing authorization for Multaq® (dronedarone - 400mg Tablets) in all 27 European member states. This approval follows the European Commission positive opinion issued on September 25, 2009 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine agency (EMEA). Bayer Schering Pharma AG, Germany, will develop a new BiTE antibody for the treatment of solid tumors in collaboration with the biopharmaceutical company Micromet, Inc. In January 2009, both companies had entered into an option, license and collaboration agreement. By exercising the option now, Bayer Schering Pharma has triggered a joint collaboration on the development of the BiTE antibody against an undisclosed solid tumor target through the completion of Phase I clinical trials, at which point Bayer will assume full control of the further development and commercialization of the antibody. 
Boehringer Ingelheim announced that the European Commission has approved Micardis® (telmisartan) for the reduction of cardiovascular morbidity in patients with:
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Committee for Medicinal Products for Human Use (CHMP), which is responsible for conducting the initial assessment of medicinal products that have been filed for marketing authorisation in Europe, has issued a negative opinion relating to the approval of Avastin (bevacizumab) alone or in combination with irinotecan chemotherapy for the treatment of relapsed or progressive glioblastoma (GBM), the most aggressive type of primary malignant brain cancer. 
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has submitted a MAA to the European Medicines Agency for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. This is the third marketing application for velaglucerase alfa that has been submitted, with previous submissions in the United States and Canada.