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Sinovac Completes Construction Of H1N1 Virus Seed Bank
Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading developer and provider of vaccines in China, announced today that it has completed construction of the H1N1 virus seed bank necessary to produce a virus antigen.
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Number Of Uninsured California Kids May Double
A new deal to balance California"s budget may have serious repercussions for the health of the state"s children, while South Carolina grapples with health cuts of its own. Meanwhile, New Jersey may become one of the first states to publically disclose hospital errors.
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Obama's Notre Dame Speech Strikes 'Forceful Blow' Against Culture Wars, Washington Post Opinion Piece Says
President Obama during his speech at Notre Dame, "fought back" antiabortion-rights protesters "not with harsh words but with the most devastating weapons in his political arsenal: a call for "open hearts," "open minds," "fair-minded words" and a search for "common ground,"" Washington Post columnist E.J. Dionne writes. Dionne continues that as "Obama"s opponents seek to reignite the culture wars," the president has "refused to join" and instead "opted for humility." Dionne writes that Obama "did all this without skirting the abortion question and without flinching from the "controversy surrounding my visit here."" In what might have been Obama"s "most radical and the most conservative speech of his presidency," he "[a]cknowledg[ed] the Roman Catholic Church"s role in supporting his early community organizing work," while drawing "on the res of Catholic social thought" that "combines opposition to abortion with a sharp critique of economic injustice and thus doesn"t squeeze into the round holes of contemporary ideology," according to Dionne.In his speech, Obama "tried to undo mistakes made early in his administration, making clearer, for example, that his revisions of an earlier Bush executive order on the rights of health professionals would continue to "honor the conscience of those who disagree with abortion,"" Dionne continues. In addition, Obama "paid more respect to opponents of stem cell research -- he spoke of their "admirable conviction about the sacredness of life" -- than he had in his original announcement altering Bush"s policies," Dionne writes. He adds that on the issue of abortion rights, "Obama endorsed a broad agenda: "Let"s reduce unintended pregnancies. Let"s make adoption more available. Let"s provide care and support for women who do carry their children to term.""However, it "was hard to square that message with the rage directed toward Obama" and Notre Dame"s president, the Rev. John Jenkins, by their opponents, Dionne says. "By facing their arguments head-on and by demonstrating his attentiveness to Catholic concerns, Obama strengthened moderate and liberal forces inside the church itself," according to Dionne. He concludes, "He also struck a forceful blow against those who would keep the nation mired in culture-war politics without end. Obama"s opponents on the Catholic right placed a large bet on his Notre Dame visit. And they lost" (Dionne, Washington Post, 5/18).
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Vyvanse CII Significantly Improved ADHD Symptoms For Children 13 Hours After Administration

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has announced that a study published online in the peer-reviewed journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse® (lisdexamfetamine dimesylate) CII significantly reduced the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 from the first time point measured (1.5 hours) up to the last time point assessed (13 hours) after administration. In this pediatric analog classroom study, treatment with Vyvanse was associated with significant improvement in behavior and attention in children at each time point measured, with improvement at 13 hours after administration. "Pediatric patients may require ADHD symptom improvement both at school and after school," said Sharon Wigal, PhD, lead investigator of the study, clinical professor of pediatrics and director of clinical trials in the Child Development Center at the University of California, Irvine. "These published data are the first to have shown duration of effect of an oral ADHD stimulant in children aged 6 to 12 at 13 hours after administration. Physicians and caregivers who are seeking a long-acting medication that provides ADHD symptom improvement from morning through homework and family time may want to consider this Vyvanse study data." On May 22, 2009, the US Food and Drug Administration (FDA) approved a change to the prescribing information for Vyvanse to include supplemental data that demonstrated significant ADHD symptom improvement in children aged 6 to 12 from the first time point measured (1.5 hours) up to 13 hours postdose. Vyvanse is now the first and only oral ADHD stimulant treatment to have efficacy at 13 hours after administration for pediatric patients included in its product labeling. "Shire is proud to be at the forefront of ADHD research and treatment development and is committed to providing patients with effective ADHD medications, such as Vyvanse," said Liza Squires, MD, Research and Development Business Unit Leader for Shire. "These findings provided further support that Vyvanse can be an important treatment option for children who require duration of ADHD symptom improvement throughout the day." Vyvanse Demonstrated Significant Symptom Improvement at 13 Hours After Administration The study was a randomized, double-blind, placebo-controlled, analog classroom study that assessed the efficacy and safety of Vyvanse in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with Vyvanse at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of Vyvanse the first week and placebo the second week. The second group received placebo the first week and their optimal dose of Vyvanse the second week. The primary objective of this study was to assess the time of onset of Vyvanse compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives included assessment of the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D scale, and assessment of efficacy and time of onset of Vyvanse compared with placebo as measured by SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales. In the study, Vyvanse demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. Further, Vyvanse treatment was associated with significant efficacy as measured by both subjective (SKAMP-D and SKAMP-A) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day, and at all time points in between (2.5, 5.0, 7.5, 10.0, and 12.0 hours). Safety was also evaluated during the study. The adverse event profile for Vyvanse was similar to other currently marketed stimulants. The most frequently reported adverse events (greater than or equal to 10 percent) in the dose-optimization phase for patients taking Vyvanse were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and affect lability. Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. To date, more than 6 million Vyvanse prescriptions have been filled, bringing the current US market share to over 12 percent based on weekly branded prescription volume. Additionally, Shire has executed agreements with 10 of Shire"s top 11 managed care organizations (MCOs) to cover Vyvanse in a preferred formulary position. Vyvanse is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times. Additional information about Vyvanse and Full Prescribing Information, including Medication Guide, are available at http://www.vyvanse.com. Matthew Cabrey Porter Novelli


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