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FDA Approves Boston Scientific's TAXUS(R) Liberte(R) Long Stent
Boston Scientific Corporation (NYSE: BSX) announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS((R)) Liberte((R)) Long Paclitaxel-Eluting Coronary Stent System, a next-generation drug-eluting stent (DES) designed for long lesions. At 38 mm, it is the longest available DES, providing doctors an option that can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs. It affords a more efficient treatment option for the estimated 8 to 10 percent(1) of patients with long lesions. The Company plans to launch the product in the U.S. next month. It received CE Mark approval in 2007.
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Supreme Court Nominee Sotomayor Pledges 'Fidelity To The Law' As Confirmation Hearing Begins
In the first day of her confirmation hearings before the Senate Judiciary Committee, Supreme Court nominee Judge Sonia Sotomayor said on Monday that "fidelity to the law" is central to her judicial philosophy and that the role of a judge is "not to make law" but "to apply the law," the Washington Post reports. Sotomayor said her record as a district and federal appeals judge "reflects my rigorous commitment to interpreting the Constitution according to its terms, interpreting statutes according to their terms and Congress" intent, and hewing faithfully to precedents established by the Supreme Court and by my circuit court." She also said her "personal and professional experiences help me listen and understand, with the law always commanding the result in every case" (Barnes et al., Washington Post, 7/14). The first day of the hearings was dedicated to opening statements from Sotomayor and senators, with the questioning portion scheduled to begin on Tuesday. According to the Wall Street Journal, Sotomayor is expected to be confirmed, as Democrats outnumber Republicans on the committee 12-7 and hold a 60-member majority in the Senate (Bravin/Bendavid, Wall Street Journal, 7/14). The New York Times reports that senators from both parties are likely to use Sotomayor"s confirmation as a way to frame the debate for the next Supreme Court nominee, with Democrats hoping to "build a lopsided victory" to give President Obama more leeway to choose a more liberal nominee. Conservatives, on the other hand, "hoped to draw a line making the president think twice about picking someone" like Sotomayor in the future, the Times reports (Baker/Lewis, New York Times, 7/14).In Monday"s hearing, both parties gave indications of how they plan to proceed for the rest of the confirmation process, the Post reports. Democrats in their statements portrayed Sotomayor as a role model for the country and a judge with a modest approach who would bring balance to the conservative-leaning court (Washington Post, 7/14). Sen. Charles Schumer (D-N.Y.) said Sotomayor "puts rule of law above everything else." He added, "Given her extensive and evenhanded record, I am not sure how any member of this panel can sit here today and seriously suggest that she comes to the bench with a personal agenda" (Stern/Perine, CQ Today, 7/13). Republicans used their statements to cast Sotomayor as a partial judge, saying previous statements and rulings show she is an activist judge (Washington Post, 7/14). In particular, GOP senators on the committee referenced a comment from a 2001 speech in which Sotomayor said that a "wise Latina" would reach better decisions than a white man in some cases (Baker/Lewis, New York Times, 7/14). Sen. Jeff Sessions (Ala.), the ranking Republican on the committee, said, "No senator should vote for an individual ... who believes it is acceptable for a judge to allow their own personal background, gender, prejudices or sympathies to sway their decision." He continued, "Call it empathy, call it prejudice or call it sympathy, but whatever it is, it"s not law" (Wall Street Journal, 7/14). However, Sen. Lindsey Graham (R-S.C.) noted that Republicans lost in last year"s presidential election and told Sotomayor, "Unless you have a complete meltdown, you"re going to get confirmed" (Lewis, New York Times, 7/14).Antiabortion-Rights Protesters Arrested During HearingsFour antiabortion-rights protesters were arrested for shouting comments during the senators" remarks (CQ Today, 7/13). One of the arrested protesters was Norma McCorvey, the plaintiff "Jane Roe" in Roe v. Wade. According to the AP/Google.com, McCorvey began screaming that Sotomayor was "wrong" about abortion during the opening statement of Sen. Al Franken (D-Minn.). McCorvey and the other three arrested protesters were charged with unlawful conduct-disruption of Congress. The protesters also prompted a warning from Senate Judiciary Committee Chair Patrick Leahy (D-Vt.), who said, "We"ll show respect to everybody who is here, we will show respect to everyb
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Watchdog May Sue Bayer Over Claim That Vitamin Pill Reduces Prostate Cancer Risk
US consumer watchdog Center for Science in the Public Interest (CSPI) has informed Bayer Healthcare that it will sue them and file a complaint
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Virulence Of Pandemic H1N1 Virus: K-State Study

Laboratory studies at Kansas State University and the work of a K-State researcher are making headway in the effort to control the pandemic H1N1 virus. Juergen Richt is a Regents Distinguished Professor at K-State"s College of Veterinary Medicine and is a Kansas Bioscience Authority Eminent Scholar. His work at K-State and with outside collaborators is revealing the characteristics of the pandemic H1N1 virus. Richt is among the K-State researchers who study zoonotic disease -- those that can be transmitted from animals to humans and vice versa. Zoonotic diseases will be a focus of the National Agro and Bio-Defense Facility that has been designated for Manhattan. "Our strength at K-State is that we are very familiar with zoonotic diseases and we can contribute by working on models for animal and human diseases," Richt said. "This expertise is very critical now that an agent causing a pandemic flu in humans most likely originated in animal populations." At K-State, Richt is leading in vitro research to develop better testing tools, creating a "diagnostic arsenal" if H1N1 were to spread to swine populations. Richt said they are developing diagnostic tools for the direct detection of the virus by finding nucleic acids or other parts of the virus in a sample, as well as tools for indirect detection. The latter approach is done by creating diagnostics that detect antibodies produced by animals infected with the virus. "We do this work to protect the pig industry in case the virus would jump into the swine population," Richt said. His work with outside collaborators is testing the virulence of pandemic H1N1 in animal models. In pigs, Richt and his fellow researchers found that pandemic H1N1 does infect pigs and transmits between the animals but is not fatal. "Its important to know the clinical and pathological effects this virus has on pigs," Richt said. "It is also important to perform these experiments because we produce reagents in the pigs that we use later for diagnostic purposes as controls to validate our testing systems." The researchers also studied the virulence of two strains of the pandemic H1N1 virus in a nonhuman primate model as a way to predict how the strains would affect humans. Comparing an isolate from California with one from Mexico, Richt and his collaborators found that the California isolate was more virulent than the Mexico isolate. Both pandemic H1N1 viruses are more virulent than seasonal H1N1 flu viruses. "With different isolates, there are different clinical outcomes," he said. Establishing animal models for pandemic H1N1 is important, Richt said, because physicians have two types of antiviral medications to treat influenza. One type, called adamantine-like drugs, targets the M2 protein; the other type includes drugs like Tamiflu that target the neuraminidase protein. He said that this pandemic H1N1 is already resistant to the M2 inhibitors but still is sensitive to Tamiflu. "Some pandemic flu isolates from humans have now shown resistance to the Tamiflu," Richt said. "So the big issue now is if these Tamiflu-resistant strains take over, we have no drug to treat infected patients. And because we don"t have a vaccine yet in the United States, this might be a problem. "Pandemic H1N1 is another example of how important it is to work on the nexus of human and animal health," he said. Juergen Richt Kansas State University


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