AstraZeneca Submits Marketing Authorisation Application To European Union For Cardiovascular Drug Axanum
AstraZeneca has submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for a product combining low-dose ASA (acetylsalicylic acid) and the active ingredient of Nexium (esomeprazole) for the prevention of cardio- and cerebrovascular (CV) events in patients requiring continuous low-dose ASA treatment who are at risk of developing ASA-associated gastric and/or duodenal ulcers. Pending approval, the proposed trade name for the product is Axanum. 
Results from a Phase 3 study demonstrate MACUGEN® (pegaptanib sodium) significantly improved vision in patients with diabetic macular edema (DME), a complication of diabetes that is a leading cause of blindness in people of working age.(1) In the study, 37 percent of patients treated with MACUGEN gained two lines, or 10 letters, of vision on the ETDRS eye chart at 54 weeks, compared to 20 percent of patients who received a sham (placebo-like) procedure which consists of anesthesia and a simulated injection in the eye (p=0.0047). 
Merck announced the launch of the Merck Oncology Collaborative Trials Network, a pioneering clinical trial network focusing on the development of Merck drug and vaccine candidates being investigated for the treatment and prevention of cancer. The global network comprises leading cancer research centers who will partner with Merck to speed the development of innovative treatments for a range of cancers. 
Amgen Inc. (Nasdaq: AMGN) announced that the European Commission (EC) has granted marketing authorization for Prolia(R) (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. Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein. 
Abbott (NYSE: ABT) announced the European approval and launch of its TREK(TM) Coronary Dilatation Catheter for the treatment of coronary artery disease. The TREK system represents a new approach to balloon catheter design, and provides physicians with a high-performing option for treating challenging lesions and difficult-to-reach blockages. Abbott received CE Mark for the TREK system earlier this year.