A new era for patients with atrial fibrillation - Dabigatran etexilate at the forefront
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. 
GlaxoSmithKline (GSK) confirmed that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine, Cervarix®. The approval from the European Commission is important as it recognises the extent of cervical cancer protection demonstrated by Cervarix®, which was not highlighted by the previous indication. 
Amgen (Nasdaq: AMGN) announced top-line results from a randomized Phase 3 trial evaluating Vectibix(R) (panitumumab) as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer. The data showed the addition of Vectibix to platinum-based chemotherapy did not result in a statistically significant improvement in overall survival, the primary endpoint, compared to chemotherapy alone [median 11.1 months versus 9.0 months, hazard ratio 0.87 (95% CI: 0.73, 1.05)]. 
Pfizer Inc. (NYSE: PFE) has reported financial results for second-quarter 2010. Since the acquisition of Wyeth was completed on October 15, 2009, legacy Wyeth products and operations are reflected in the first two quarters of 2010, but not reflected in the first two quarters of 2009. Second-quarter 2010 revenues were $17.3 billion, an increase of 58% compared with $11.0 billion in the year-ago quarter.