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Schizophrenia And Bipolar Disorder Share Genetic Roots
A trio of genome-wide studies - collectively the largest to date - has pinpointed a vast array of genetic variation that cumulatively may account for at least one third of the genetic risk for schizophrenia. One of the studies traced schizophrenia and bipolar disorder, in part, to the same chromosomal neighborhoods.
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Study Shows Decreased Risk Of Death From Opportunistic Infections With Earlier Antiretroviral Treatment
HIV-positive people with opportunistic infections who receive earlier antiretroviral treatment lower their risk of death compared with people who delay treatment, according to a new study conducted by the Stanford University School of Medicine and published in PLoS One, the San Jose Mercury News reports. The findings could lead to changes in recommendations for antiretroviral treatment protocol, specifically for patients diagnosed with HIV at an advanced stage, the Mercury News reports. The study included 262 HIV-positive participants at 39 health care sites across the U.S., and 20 participants in South Africa. During the yearlong study, the researchers found that among the participants who were treated promptly after developing an opportunistic infection, 14% died or developed another infection. The researchers also found that 24% of participants who deferred treatment for an average of 45 days died or had a decrease in health outcomes. According to the Mercury News, the question of when to start HIV-positive people on antiretroviral treatment remains unclear because of issues such as the high cost of medicines, side effects, and drug interactions or resistance. Andrew Zolopa, head of Stanford University School of Medicine"s division of infectious diseases and lead investigator of the study, said that physicians often treat HIV-positive people for an "acute crisis, then follow up later with treatment for HIV." He continues, "But that answer is wrong. The study shows very clearly that there is no safety downside to doing this -- and the benefit is quite substantial, reducing death by 50%." "Even in San Francisco, one of the first epicenters of HIV in the United States, we still find that many people present late in the course of their illness with an opportunistic infection," Mitch Katz, director of San Francisco"s Department of Health who was not involved in the study, said. He added, "This study shows that it is lifesaving to treat those persons with antiretroviral drugs while they are still in the hospital." Katz said that the results could lead to changes in HIV/AIDS practices worldwide. The International AIDS Society, CDC and the British AIDS Society have developed guidelines recommending that early antiretroviral treatment be considered in patients with opportunistic infections, Zolopa said. In addition, NIH is considering an international study to examine earlier initiation of antiretroviral treatment involving more than 9,000 people from both developed and developing countries (Krieger, San Jose Mercury News, 5/15).
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Study Pinpoints Drugs That Prevent Epilepsy, Seizures After Severe Brain Injury
Drugs that block a growth factor receptor on brain cells may prevent epilepsy after brain damage, according to a new study appearing in the July 15 issue of the Journal of Neuroscience.
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FDA Accepts SNDA For Alternative Dosing Regimen For Dacogen(R) (decitabine For Injection) To Treat Patients With Myelodysplastic Syndromes (MDS)

Eisai Corporation of North America announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company"s supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen(R) (decitabine for injection) to treat patients with myelodysplastic syndromes (MDS). MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells. Currently, Dacogen is approved for use as a three-day regimen, administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six weeks. The alternative five-day dosing regimen of Dacogen(R) submitted to the U.S. FDA is a single daily dose with a significantly reduced administration time. If approved, patients with MDS may experience increased convenience with the new dosing regimen. "We"re pleased that the FDA has agreed to review our application for the alternative dosing regimen, and we look forward to working with the agency throughout the review process," said Cynthia Schwalm, President of Eisai Inc. "This application is one part of a full complement of clinical development programs we have committed for Dacogen and is a vital part of our human health care mission of increasing patient benefits and fulfilling unmet medical needs." Acceptance of the sNDA means that FDA has found the company"s submission to be sufficiently complete to review. About Dacogen The safety profile of decitabine for injection is well characterized. Dacogen (decitabine for injection) was approved by the FDA on May 2, 2006, and is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2 and High-Risk International Prognostic Scoring System (IPSS) groups. Dacogen may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen. Men should be advised not to father a child while receiving treatment with Dacogen and for two months afterwards. The most commonly occurring adverse reactions with Dacogen include neutropenia (90 percent), thrombocytopenia (89 percent), anemia (82 percent), pyrexia (53 percent), fatigue (48 percent), nausea (42 percent), cough (40 percent), petechiae (39 percent), constipation (35 percent), and diarrhea (34 percent). About Eisai Corporation of North America Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd. and supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery. Eisai Corporation of North America


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