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Positive CHMP Opinion For JAVLOR(R) In Metastatic Treatment Of Bladder Cancer After Failure Of A Prior Platinum-Containing Regimen
Laboratoires Pierre Fabre announce that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency (EMEA), has issued a positive opinion supporting approval and is recommending to grant marketing authorisation for JAVLOR(R) as monotherapy in metastatic treatment of bladder cancer (advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen).
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States Consider Scaling Back Funding For Medicare Drug Benefit Amid Economic Crisis
At least six states have considered eliminating or reducing financial assistance for those enrolled in the Medicare prescription drug benefit program who are affected by the "doughnut hole," or gap in coverage, the AP/Boston Herald reports. According to the AP/Herald, the governors of Rhode Island and Vermont and lawmakers in South Carolina have proposed plans to eliminate such financial assistance programs, while Massachusetts has reduced funding for its program. Meanwhile, proposals in New York and Connecticut to limit financial help have been dismissed.Beneficiaries enrolled in the drug benefit have coverage until total spending reaches $2,700 and then must pay out-of-pocket for their medications until the total spending reaches $4,350, after coverage. At least 16 states provide financial help to beneficiaries who have reached the coverage gap (AP/Boston Herald, 5/27).
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People With Intellectual Or Developmental Disabilities Particularly Vulnerable To Effects Of Tobacco Use And Dependence
While tobacco use is an ongoing health hazard for the entire population, its consequences for people with developmental or intellectual disabilities can be especially severe. And the medical community often tends to overlook the tobacco-related burdens these people face. An extensive review of published research on this topic appears in the June edition of the journal Intellectual and Developmental Disabilities.
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Yale Researchers Suggests Gene Inhibition May Help Normalize Type 2 Diabetes

In research that could lead to new approaches for the treatment of type 2 diabetes, a Yale School of Medicine team has found that suppressing a liver enzyme that induces glucose production helped diminish the symptoms of the disease in a rat model - reducing blood glucose concentrations, decreasing rates of glucose production in the liver, and improving insulin sensitivity. Decreasing expression of the gene, Sirtuin 1, also lowered total cholesterol levels. The research appears in the June 15-19 Online Early Edition of the Proceedings of the National Academy of Sciences. Type 2 diabetes is characterized by high blood glucose concentrations and insulin resistance, which play a major factor in causing the disease. In the U.S., rates of type 2 diabetes have doubled since 1990, and the Centers for Disease Control calls the disease an epidemic. Formerly known as "adult-onset diabetes," the disorder is increasingly diagnosed in children. The Yale researchers put the rats on a four-week diet of fructose and high-fat meals to create a metabolic condition that mimics type 2 diabetes. At the same time, they inhibited expression of the Sirtiun 1 gene through injection of an antisense oligonucleotide (short fragments of nucleic acid that inactivate gene expression) specifically targeted to that gene. "Blood glucose levels in the rats came down close to normal, as did their ability to regulate blood glucose levels with insulin," said first author Derek Erion, a graduate student in cellular and molecular physiology at Yale. The authors believe the falling plasma cholesterol levels that also resulted may be attributed to increased cholesterol uptake and export from the liver, due to suppression of key enzymes involved in cholesterol metabolism. Senior author Gerald Shulman, MD, said the results indicate that inhibiting Sirtuin 1 in the liver may be an attractive approach for the treatment of type 2 diabetes. "With this disorder, diet and exercise only get you so far," he said. "Many patients may need drug intervention to avoid suffering the debilitating effects of type 2 diabetes." Shulman is the George R. Cowgill Professor of Physiological Chemistry, Medicine and Cellular and Molecular Physiology at Yale and a Howard Hughes Medical Institute Investigator. Other authors include: Shin Yonemitsu, Yoshio Nagai and Matthew P. Gillum of the Yale School of Medicine and Howard Hughes Medical Institute; Jennifer J. Hsiao, Takanori Iwasaki, Romana Stark, Dirk Weismann, Varman T. Samuel, Tamas. L. Horvath and Qian Gao of Yale School of Medicine; Xing Xian Yu, Susan F. Murray, Sanjay Bhanot and Brett P. Monia of Isis Pharmaceuticals in Carlsbad, CA. The work above was funded in part by the Yale Clinical and Translational Science Award (CTSA) grant from the National Center for Research Res at the National Institutes of Health. Yale University


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