Amgen Receives CHMP Positive Opinion for Prolia(TM) (Denosumab) in the European Union
Amgen Inc. (Nasdaq: AMGN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for the marketing authorization of Prolia((TM)) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. If approved by the European Commission, Amgen would receive marketing authorization for Prolia in all European Union (EU) Member States. 
Boehringer Ingelheim announced very positive results from their landmark RE-COVER™ study - the most advanced trial programme assessing a novel oral anticoagulant in development for acute venous thromboemolism (VTE) treatment - presented at the American Society of Hematology Annual Meeting(1) and published in the New England Journal of Medicine online.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced new long-term follow up-data from two large pivotal studies evaluating adjuvant Herceptin in HER2-positive early- stage breast cancer presented at the San Antonio Breast Cancer Symposium (SABCS). Both studies, N9831 conducted by the North Central Cancer Treatment Group (NCCTG) and BCIRG006 performed by the Breast Cancer International Research Group consistently showed that Herceptin reduced the risk of the cancer returning by about one third in women with HER2-positive early breast cancer compared to patients receiving chemotherapy alone. 
The European Commission has granted Pfizer Inc. (NYSE: PFE) a European marketing authorization for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]). Prevenar 13 is indicated for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 Streptococcus pneumoniae serotypes in infants and children from 6 weeks to 5 years of age. Invasive pneumococcal disease includes sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema.
GlaxoSmithKline today announced initiation of the second large-scale Phase III clinical trial to evaluate long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with acute coronary syndrome (ACS). The study, called SOLID-TIMI 52 (The Stabilisation of pLaque Using darapladib - Thrombolysis In Myocardial Infarction 52), will include 11,500 patients from 40 countries. 
Novartis is set to sustain its leading global position in oncology by expanding the range of indications for several marketed therapies and developing its competitive development pipeline with 16 new molecular entities focused on various life-threatening diseases, senior executives told investors.
Bayer Schering Pharma AG, Germany, has successfully completed the decentralized part of drug approval procedure in Europe for a new treatment of endometriosis called Visanne®. Visanne is a once-daily oral tablet containing dienogest 2 mg that has been developed specifically for the treatment of endometriosis.