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Study examines effects of dietary weight loss, exercise on insulin resistance among postmenopausal women

BY Allison Cerra

NEW YORK — A new study that is slated to appear in the October issue of the American Journal of Preventive Medicine found that postmenopausal women may improve their insulin sensitivity through such interventions as diet, exercise, or a combination of the two.

The subjects, which were inactive, overweight/obese postmenopausal women between the ages of 50 and 70 years, were assigned to one of the following groups during the study: dietary weight-loss program (118 subjects); exercise program (117 subjects); a combined program of exercise and diet (117 subjects); or control (87 subjects). The diet intervention was a group-based reduced-calorie program with a 10% weight-loss goal, while the exercise intervention was 45 min/day, 5 days/week of moderate-to-vigorous intensity aerobic activity, the researchers said.

The research, which was conducted between 2005 and 2009 and analyzed in 2010, found that the diet and diet/exercise combination programs garnered the best results, with insulin resistance decreasing by 24% and 26%, respectively. Groups in the exercise and control groups only saw respective decreases of 9% and 2%. These effects were similar in middle-aged (ages 50 to 60 years) and older women (ages 60 to 75 years).

This study was supported by a grant from the National Cancer Institute at the National Institutes of Health.

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Report: Mylan temporarily banned from launching generic acne drug

BY Alaric DeArment

NEW YORK — Mylan will be banned temporarily from launching a generic drug for acne pending a federal court’s decision whether or not to bar it, according to published reports.

According to Bloomberg, the U.S. District Court for the District of Delaware ruled that Mylan violated 1-of-4 patents covering the acne drug Oracea (doxycycline), sold by Galderma Labs. Galderma, New York University and the Research Foundation of the State University of New York sued Mylan for patent infringement related to the drug in 2009. The court will wait to decide whether to bar Mylan from launching.

Patents covering Oracea are scheduled to expire between Aug. 30, 2016, and Dec. 19, 2027, according to Food and Drug Administration records.

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FDA accepts application for opioid-induced constipation drug

BY Alaric DeArment

TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.

The drug originally was approved for treating patients taking opioids for cancer pain, but the companies are seeking approval for OIC in patients with pain not related to cancer. The FDA plans to make a decision on the drug by April 27, 2012.

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