Business & Industry News Channel
AstraZeneca announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. 
Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that data from the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) were presented at the European Society of Cardiology's Congress 2010 in Stockholm, Sweden. The study met its primary endpoint with a 28 percent reduction in LDL-cholesterol, compared with an increase of 5 percent for placebo (p<0.001). 
Stefan Brinkmann, Managing Director of Nycomed GmbH, kicked off the German market launch of Daxas® (Roflumilast) in Oranienburg today, making Germany the first country to market the medicine. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that was developed by Nycomed to treat the progressive, life-threatening lung disease COPD. 
The European Society of Cardiology (ESC) issued revised practice guidelines for the management of atrial fibrillation (AF), including guidance on the role of a novel oral treatment, dabigatran etexilate, for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). At the same time, Boehringer Ingelheim confirms that the U.S. Food and Drug Administration (FDA) granted a priority review designation for Boehringer Ingelheim's novel oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke in AF. A new genetic substudy of PLATO (A Study of PLATelet Inhibition and Patient Outcomes) showed that the effects on a combined primary endpoint of cardiovascular death, myocardial infarction, or stroke seen in Acute Coronary Syndromes (ACS) patients who received the investigational oral antiplatelet treatment, ticagrelor (BRILINTA™), were maintained, whether or not they had the genetic variability that has been previously shown to affect a patient's response to clopidogrel. 
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that the European Commission has granted marketing authorisation for VPRIV® (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease. VPRIV has been authorized as an orphan medicine through the Centralised Procedure, making it available in 30 countries across Europe. 
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) report that preliminary results from the Phase 3 AVERROES clinical trial of the investigational drug apixaban compared with acetylsalicylic acid (ASA, or aspirin) in patients with atrial fibrillation expected to be or demonstrated to be unsuitable for warfarin therapy will be presented at the European Society of Cardiology Congress 2010. The results will be presented during the "Hot Line" session on August 31, 2010, in Stockholm, Sweden. 