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FDA Appointed Arthritis Advisory Committee Recommends U.S. Food And Drug Administration Approval For KRYSTEXXA(TM) For Refractory Chronic Gout
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a vote of 14 to 1 that KRYSTEXXA(TM) (pegloticase), a biologic PEGylated uricase enzyme, be granted marketing approval by the FDA for the treatment of refractory chronic gout. Refractory chronic gout or treatment failure gout (TFG) is gout in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with conventional urate-lowering therapy at the maximum medically appropriate dose or for whom conventional urate-lowering therapy is contraindicated. The current target Prescription Drug User Fee (PDUFA) action date for the FDA"s decision as to whether to grant marketing approval for KRYSTEXXA is August 1, 2009.
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Missouri Judge Approves Summary, Cost Estimate For Abortion Ballot Proposal
Missouri Judge Patricia Joyce last week dismissed conspiracy allegations against three state officials and approved the summary and cost estimate for a proposed constitutional amendment that would ban public funding for abortions and certain types of embryonic stem cell research, the AP/St. Louis Post-Dispatch reports.The Missouri Roundtable for Life proposed the ballot measure earlier this year. Supporters of the measure subsequently argued that a summary written by Missouri"s secretary of state was biased. At the same time, opponents of the measure argued that the original petition was improperly drafted and should not have been allowed to proceed.Joyce dismissed the challenges to the summary and cost estimate, which was prepared by the state auditor. She also rejected the Roundtable"s claims that three state officials -- Secretary of State Robin Carnahan, Attorney General Chris Koster and State Auditor Susan Montee -- conspired to violate sponsors" constitutional rights. Joyce ruled that the allegations "are without merit and rise to the level of being frivolous."Steve Clark, an attorney representing the Roundtable, said his clients have not yet decided whether they will appeal. If they appeal and the summary is changed, new signatures will be required to support the new language. Supporters hope to place the measure on the 2010 ballot (Blank, AP/St. Louis Post-Dispatch, 6/20).
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The Minister For Health&Children Commences The Outstanding Sections Of The Pharmacy Act 2007 Dealing With Complaints, Inquires And Discipline, Ireland
The Minister for Health and Children, Mary Harney TD, announced the commencement of the outstanding Sections of the Pharmacy Act 2007 to provide for the introduction of a Complaints, Inquires and Discipline regime for pharmacists and pharmacy businesses. Also included are Sections 63 and 64 of the Act, which relate to the prohibition of certain economic relationships between pharmacists or pharmacies and medical practitioners, or medical practices.
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BPA, Chemical Used To Make Plastics, Found To Leach From Polycarbonate Drinking Bottles Into Humans Exposure To BPA May Have Harmful Health Effects

A new study from Harvard School of Public Health (HSPH) researchers found that participants who drank for a week from polycarbonate bottles, the popular, hard-plastic drinking bottles and baby bottles, showed a two-thirds increase in their urine of the chemical bisphenol A (BPA). Exposure to BPA, used in the manufacture of polycarbonate and other plastics, has been shown to interfere with reproductive development in animals and has been linked with cardiovascular disease and diabetes in humans. The study is the first to show that drinking from polycarbonate bottles increased the level of urinary BPA, and thus suggests that drinking containers made with BPA release the chemical into the liquid that people drink in sufficient amounts to increase the level of BPA excreted in human urine. The study appears on the website of the journal Environmental Health Perspectives and is freely available here. In addition to polycarbonate bottles, which are refillable and a popular container among students, campers and others and are also used as baby bottles, BPA is also found in dentistry composites and sealants and in the lining of aluminum food and beverage cans. (In bottles, polycarbonate can be identified by the recycling number 7.) Numerous studies have shown that it acts as an endocrine-disruptor in animals, including early onset of sexual maturation, altered development and tissue organization of the mammary gland and decreased sperm production in offspring. It may be most harmful in the stages of early development. "We found that drinking cold liquids from polycarbonate bottles for just one week increased urinary BPA levels by more than two-thirds. If you heat those bottles, as is the case with baby bottles, we would expect the levels to be considerably higher. This would be of concern since infants may be particularly susceptible to BPA"s endocrine-disrupting potential," said Karin B. Michels, associate professor of epidemiology at HSPH and Harvard Medical School and senior author of the study. The researchers, led by first author Jenny Carwile, a doctoral student in the department of epidemiology at HSPH, and Michels, recruited Harvard College students for the study in April 2008. The 77 participants began the study with a seven-day "washout" phase in which they drank all cold beverages from stainless steel bottles in order to minimize BPA exposure. Participants provided urine samples during the washout period. They were then given two polycarbonate bottles and asked to drink all cold beverages from the bottles during the next week; urine samples were also provided during that time. The results showed that the participants" urinary BPA concentrations increased 69% after drinking from the polycarbonate bottles. (The study authors noted that BPA concentrations in the college population were similar to those reported for the U.S. general population.) Previous studies had found that BPA could leach from polycarbonate bottles into their contents; this study is the first to show a corresponding increase in urinary BPA concentrations in humans. One of the study"s strengths, the authors note, is that the students drank from the bottles in a normal use setting. Additionally, the students did not wash their bottles in dishwashers nor put hot liquids in them; heating has been shown to increase the leaching of BPA from polycarbonate, so BPA levels might have been higher had students drunk hot liquids from the bottles. Canada banned the use of BPA in polycarbonate baby bottles in 2008 and some polycarbonate bottle manufacturers have voluntarily eliminated BPA from their products. With increasing evidence of the potential harmful effects of BPA in humans, the authors believe further research is needed on the effect of BPA on infants and on reproductive disorders and on breast cancer in adults. "This study is coming at an important time because many states are deciding whether to ban the use of BPA in baby bottles and sippy cups. While previous studies have demonstrated that BPA is linked to adverse health effects, this study fills in a missing piece of the puzzle-whether or not polycarbonate plastic bottles are an important contributor to the amount of BPA in the body," said Carwile. The study was supported by the Harvard University Center for the Environment and the National Institute of Environmental Health Sciences Biological Analysis Core, Department of Environmental Health, HSPH. Carwile was also supported by the Training Program in Environmental Epidemiology. "Use of Polycarbonate Bottles and Urinary Bisphenol A Concentrations," Jenny L. Carwile, Henry T. Luu, Laura S. Bassett, Daniel A. Driscoll, Caterina Yuan, Jennifer Y. Chang, Xiaoyun Ye, Antonia M. Calafat, Karin B. Michels, Environmental Health Perspectives, online May 12, 2009. Harvard School of Public Health


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