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Gene Variant That Increases Ovarian Cancer Risk Discovered
By searching millions of DNA variations in the genomes of thousands of women with and without ovarian cancer, scientists have discovered a
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Oculus Innovative Sciences Receives FDA Clearance For Microcyn(R) Skin And Wound Gel
Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), a healthcare company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Microcyn® Skin and Wound Gel as both a prescription and over-the-counter formulation. The Rx product, under the supervision of a health care professional, is intended for management of exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically debrided wounds. This is the first hydrogel product based upon the Microcyn Technology platform and is reimbursable by both Medicare and Medicaid.
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News of the day
Arizona, North Carolina Legislatures Take Action On Abortion, Sex Education Measures
The following summarizes news coverage on women"s health-related legislation in Arizona and North Carolina. ~ Arizona: The Arizona Senate Public Safety and Human Services Committee on Wednesday voted 4-3 to approve a bill (S.B. 1206) that would place several restrictions on abortion rights and allow pharmacists or other health care providers to refuse to distribute emergency contraception based on religious or moral objections, the AP/Arizona Daily Star reports. The state House passed an identical bill in March. The measure would impose a 24-hour waiting period for women seeking abortion procedures and mandate that doctors inform women about risks and alternatives. It also would toughen an exisiting parental consent requirement for minors seeking abortion. The bill requires an in-person consultation before the 24-hour waiting period, which would increase costs for women who are forced to travel to a clinic twice, according to Planned Parenthood of Arizona President Bryan Howard. The Legislature approved bills with similar restrictions in recent years, but the measures were vetoed by then-Gov. Janet Napolitano (D). Current Gov. Jan Brewer (R) has said she supports mandatory disclosures and a 24-hour waiting period (Billeaud, AP/Arizona Daily Star, 6/10).~ North Carolina: The North Carolina Senate Mental Health and Youth Services Committee this week approved a bill (S. 221) that would require all public school systems to offer information on the use of contraceptives to students in grades seven through nine, the AP/Raleigh News & Observer reports. The information would be presented as part of a larger reproductive health education program that would maintain the abstinence-only education curricula currently taught at nearly all of the state"s 115 school districts. Parents would be permitted to prevent children from participating in the classes with contraceptive information. The measure is a revised version of state House-approved legislation (H.B. 88) that would have required schools to teach two separate abstinence-only and comprehensive sex education tracks. If the full state Senate passes the new bill, the two chambers will meet to negotiate a compromise (Robertson, AP/Raleigh News & Observer, 6/11).
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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