Popular Articles

Health Outcomes Explored At DDW 2009: Environmental Pollution Increases The Risk Of Liver Disease
A new study is the first to show that there is a previously unrecognized role for environmental pollution in liver disease in the general U.S. adult population. This work builds upon the groups" previous research demonstrating liver disease in highly-exposed chemical workers. The study is being presented during Digestive Disease Week® 2009 (DDW®), the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

Stem Cell Lawyer Says Let Women Be Paid For Egg Donations
Last week, New York became the first state in America to allow scientists to pay women for donating their eggs for use in stem cell research, triggering further ethical debate. Professor Loane Skene of the Faculty of Law at the University of Melbourne and Deputy Chair of the high-profile Lockhart Committee on Human Cloning and Embryo Research (2005) says women should be paid for the invasive procedure.
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Researchers Reveal Selenium's Metabolism In Life-Giving Amino Acids
US researchers have discovered the molecular mechanisms by which the human body metabolizes selenium, a trace element that plays an essential
Medical Devices

POZEN Submits New Drug Application For VIMOVO™ (PN 400)

POZEN Inc. (NASDAQ:POZN), announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVO™ (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca entered into a global co-development agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers. The NDA submission is based on data from a comprehensive clinical trials program. POZEN conducted two pivotal studies (301/302) under a special protocol assessment agreed with the FDA, which met their primary endpoints. In the 301/302 studies, significantly fewer subjects taking VIMOVO experienced endoscopically confirmed gastric ulcers compared to subjects receiving EC naproxen. The primary endpoint was the cumulative incidence of gastric ulcers through six months. In each of the trials, approximately 400 subjects received either VIMOVO or EC naproxen (500 mg), twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months. Upon the FDA"s acceptance for filing of the NDA, a $10 million milestone payment from AstraZeneca will be payable to POZEN. About Osteoarthritis Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain, affecting nearly 140 million individuals worldwide,1 and impacting approximately 18% of women and 9.6% of men aged 60 and above.2,3 A combination of factors can contribute to osteoarthritis, including being overweight, aging, joint injury or stress, heredity and muscle weakness.4 Osteoarthritis commonly affects the hands, feet, spine or large weight-bearing joints, such as the hips and knees.5 In the U.S., the average direct cost of osteoarthritis is about $2,600 per year out-of-pocket expenses. Total annual disease costs are $5,700 (2000) and job-related osteoarthritis costs are $3.4 to $13.2 billion per year.6 POZEN


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