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FDA Accepts Final Section Of NDA Filing For LUCASSIN(R)
Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for LUCASSIN(R) (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type 1. The filing was completed on May 4, 2009, and LUCASSIN has been granted Priority Review as well as Orphan Drug status and Fast Track designation.
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Evidence-Based Information About Complementary And Alternative Medicine Treatments Now Available
More than one-third of Americans use complementary or alternative medicine (CAM). The vast majority of patients use CAM in addition to, rather than instead of, a conventional medical regimen.
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Opinion Pieces React To Obama's Nomination Of Sotomayor To Supreme Court
Several newspapers on Wednesday included editorials and opinion pieces on President Obama"s nomination of Judge Sonia Sotomayor to the Supreme Court. Summaries appear below. ~New York Times: Obama "seems to have made an inspired choice" in selecting Sotomayor as his nominee because she "has an impressive judicial record, a stellar academic background and a compelling life story," a Times editorial states. According to the editorial, "Based on what we know now, the Senate should confirm her so she can join the court when it begins its new term in October." The editorial notes that, "Conservative activists have already begun trying to paint Judge Sotomayor as a liberal ideologue, but her carefully reasoned, fact-based decisions indicate otherwise." The editorial continues, "If Judge Sotomayor joins the court, it will be a special point of pride for Hispanic-Americans," and "will also bring the paltry number of female justices back to two." It adds, "Judge Sotomayor, though, is more than just a distinguished member of two underrepresented groups. She is an accomplished lawyer and judge, who could become an extraordinary Supreme Court Justice" (New York Times, 5/27).~Gerard Magliocca, New York Times: In addition to sharing Obama"s "experience and intellect," Sotomayor "also mirror"s the president"s measured temperament," Magliocca, a law professor at Indiana University, writes in a Times opinion piece. Magliocca writes that he has known Sotomayor for 13 years and notes that although he is a conservative and has at times been "at odds with" Sotomayor professionally, he does not dispute her qualifications. According to Magliocca, "For those of us who think that intellectual rigor and fairness are the crucial factors" to be a Supreme Court justice, "no matter which party the president hails from, there is no question that Judge Sotomayor should be confirmed" (Magliocca, New York Times, 5/27).~USA Today: Upon hearing that Sotomayor was Obama"s nominee, Republican critics "quickly insisted that the Senate assure itself that Sotomayor would not make rulings based on her "personal politics, feelings and preferences,"" a USA Today editorial states. According to the editorial, "To some extent, the entire argument is overblown. People inevitably are the product of their experiences, and they can hardly shed their history and character at the courthouse door." The editorial continues, "That is why the court is enriched by having an eclectic mix of justices who can bring differing perspectives to bear on the case at hand." The editorial concludes, "Sotomayor"s education and experience make her far more than a political twofer who allowed Obama to check the "female" and "Hispanic" boxes. But there"s a limit to the application of empathy and heritage to the law, and her confirmation hearings will be an opportunity for her to spell out exactly where she believes that line falls," (USA Today, 5/27).~ Steven Waldman, Wall Street Journal: "Everyone seems to assume" that Supreme Court nominee Sonia Sotomayor is "ardently for abortion rights," but there is "stunningly little information about her abortion views -- and what we do know hardly paints her as a pro-choice activist," Waldman, president and editor-in-chief of Beliefnet.com and author of "Founding Faith," writes in a Journal opinion piece. He continues that Sotomayor has ruled only on three cases "indirectly related to abortion," and each time ruled in a way preferred by abortion-rights opponents, "albeit for reasons unrelated to the merits of abortion." Although Sotomayor"s decisions in the cases were related "to matters of constitutional law and criminal procedure, ... at a minimum, it showed that whatever her abortion views, it didn"t produce some powerful inclination against the pro-life position," according to Waldman. "Now all of this might not mean anything. She may prove to be a strong advocate of Roe v. Wade. But it"s telling that the abortion interest groups took sides without knowing anything about her abortion
Medical Devices

Is P90RSK A New Therapeutic Target For Liver Fibrosis?

Cirrhosis is a world wide, bad prognosis liver disease and characterized by excessive collagen deposition and liver function damage. In our previous work, p90RSK is observed significantly up-regulated in association with elevated collagen type I levels in rat liver fibrosis. But detail mechanism of this phenomenon is still unknown. Now, there is a research article published on May 7, 2009 in the World Journal of Gastroenterology that addresses this problem. The research team led by Professor Zhu from Department of Gastroenterology, Jinling Hospital observed the mechanism between p90RSK and collagen type I in vivo and in vitro. In fibrotic liver tissue, p90RSK was over-expressed and located in activated HSC, which had a significant positive correlation with collagen type I levels. In HSC-T6 cells transfected with RNAi targeted to p90RSK, the expression of collagen type I was down regulated according with that of p90RSK. However, collagen type I promoter activity was not alternated with up-regulation or down-regulation of p90RSK expression. Otherwise, p90RSK RNAi inhibited the proliferation of HSC significantly. These results indicate that P90RSK was a critical element in activation of HSC, which is primarily responsible for excessive collagen expression via the initiation of HSC proliferation during liver fibrosis. Lacking of the knowledge about pathological proceeding of liver fibrosis results in the lack of effective method to prevent and treat liver fibrosis. These results prefer a new view of p90RSK on liver fibrosis, and thus may provide a new therapeutic target to liver fibrosis. Reference: Yang MF, Xie J, Gu XY, Zhang XH, Davey AK, Zhang SJ, Wang JP, Zhu RM. Involvement of 90-kuD ribosomal S6 kinase in collagen type ò…  expression in rat hepatic fibrosis. World J Gastroenterol 2009; 15(17): 2109-2115 http://www.wjgnet.com/1007-9327/15/2109.asp Correspondence to: Ren-Min Zhu, Professor, Department of Gastroenterology, Jinling Hospital, Second Military Medical University, Zhongshan East Road 305, Nanjing 210002, Jiangsu Province, China. Lin Tian World Journal of Gastroenterology


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