XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
Amgen (NASDAQ: AMGN) announced that the European Commission (EC) has granted marketing authorization for XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. This approval of XGEVA applies to all 27 European Union (EU) member states. The EC also granted XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the significant clinical benefit of XGEVA in comparison with existing therapies. 
Novartis announced today that the European Commission has approved Afinitor® (everolimus) tablets for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumors (NET) of pancreatic origin in adults with progressive disease[3]. The approval was based on Phase III data from the largest clinical trial to date in advanced pancreatic NET. The RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) trial showed treatment with Afinitor more than doubled the time without tumor growth (median 4.6 to 11.0 months) and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET (hazard ratio=0.35 [95% confidence interval (CI), 0.27 to 0.45]; p<0.001). 
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Tarceva® (erlotinib) for use in patients with a genetically distinct type of non-small cell lung cancer (NSCLC) in Europe. This approval will enable the use of Tarceva as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations. Tumours with these mutations are responsive to Tarceva(1) and treatment with this medicine has been shown to more than triple the number of patients whose tumours shrink (response rate). 
At an award ceremony in Paris, the 32 winning projects of the global disease awareness initiative 1 Mission 1 Million - Getting to the Heart of Stroke were announced. The projects were chosen by the public and a panel of experts. They will be awarded a share of the €1 million donation to fulfil the overall mission of preventing as many as one million atrial fibrillation (AF)-related strokes through awareness campaigns. 1 Mission 1 Million is supported by over 45 third-party organisations around the world and is sponsored by Boehringer Ingelheim. 
AstraZeneca today announced results from a blinded review of clinical data from patients in the PLATO trial who had died following coronary artery bypass graft (CABG) surgery. The blinded review found that, when compared to clopidogrel, BRILINTA (ticagrelor) was more commonly associated with fewer cardiac, bleeding or infectious complications that directly caused or contributed to death following CABG. These data were presented today at the European Society of Cardiology (ESC) congress in Paris, France. 
Novo Nordisk is investing around 1 billion Danish kroner (134 million euros) in two new office buildings with surrounding green space in Bagsværd, Denmark. The project is expected to create more than 300 jobs during the construction phase. The new office premises will house Novo Nordisk's top management, 1,100 administrative employees and a number of shared facilities. Groundbreaking will take place in October, and the new corporate centre is expected to be ready for occupancy at the end of 2013.