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Popular Articles

Britains Next Oldest Mother Highlights Increase Of 'fertility Tourism'
At 66 years old, Elizabeth Adeney is set to become Britain"s oldest mother when she gives birth to a child conceived following fertility treatment at a clinic in Ukraine. The example highlights the growing trend among fertility patients to travel abroad to access treatment which in Britain often involves high cost and a long wait.
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Medicare Rights Center And Food Bank For New York City Awarded $1 Million To Increase Enrollment Of Low-Income New Yorkers In Assistance Programs
The Medicare Rights Center (Medicare Rights) and Food Bank For New York City (Food Bank) have joined forces to enroll poor older New York City residents in programs to help them afford health care and healthy food. Funded by a $1 million grant from the Fan Fox and Leslie R. Samuels Foundation, the two advocacy organizations will help city seniors enroll in four under-utilized assistance programs, with a total project value to enrollees of $46 million.
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"lab-On-A-Chip" Technology Advances Colorectal Cancer Screening
According to the American Cancer Society, colorectal cancer, America"s third leading type of cancer, is also one of the most preventable. One-third of all colorectal cancer deaths could be avoided by simple screening, they say. But colonoscopies, though highly effective, can also be painful, and current diagnostic techniques are time-consuming and sometimes inaccurate.
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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