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Swine Flu And The Influenza Virus In 1918
The influenza virus that wreaked worldwide havoc in 1918-1919 founded a viral dynasty that persists to this day, according to scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. In an article published online on June 29 by the New England Journal of Medicine, authors Anthony S. Fauci, M.D., Jeffery K. Taubenberger, M.D., Ph.D., and David M. Morens, M.D., argue that we have lived in an influenza pandemic era since 1918, and they describe how the novel 2009 H1N1 virus now circling the globe is yet another manifestation of this enduring viral family.

Experts To Assess Impacts And Policy Barriers To Improving Proper Medication Adherence
Health reform may succeed in creating better coverage and access for Americans, but until we reduce the barriers to proper medication adherence, many patients will not experience improved health, according to experts meeting today to discuss the challenges of adherence.
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Obama To Review Court Picks Over Weekend
President Obama on Wednesday said he would review potential Supreme Court nominees to replace retiring Justice David Souter over the weekend, prompting those involved with the process to believe he will make an announcement within days, the Washington Post reports. Obama was speaking to a group of senators that included Majority Leader Harry Reid (D-Nev.), Minority Leader Mitch McConnell (R-Ky.), Judiciary Committee Chair Patrick Leahy (D-Vt.) and the committee"s ranking Republican Sen. Jeff Sessions (R-Ala.). According to White House spokesperson Robert Gibbs, Obama told the senators that he "would choose a nominee who respects the Constitution and judicial precedent and also has the good judgment and common sense to reach fair decisions" (Murray, Washington Post, 5/14). Although a list of six to eight potential names has been circulating in public, a White House official said an official pick is not likely to be announced before Memorial Day (Weisman, Wall Street Journal, 5/14).During the meeting, the president also urged senators to act quickly during the confirmation hearing so the new justice is confirmed prior to the court"s next session, which begins in October. Obama told Reid that the goal was to hold the confirmation vote before the Senate leaves for its summer recess, for which the official adjournment date is Aug. 7 (Washington Post, 5/14). However, Republican members at the meeting "poured cold water on that idea," the Journal reports. According to McConnell, 60 days usually passes between the naming of a nominee and the first confirmation hearing in the Judiciary Committee. According to the Journal, Obama is aiming to avoid partisan controversy over the summer and "ease his choice onto the court." Obama "got a lift" from Sessions during the meeting when the senator indicated that a filibuster attempt is not in the works, the Journal reports (Weisman, Wall Street Journal, 5/14).Court Watchers Say Next Pick Likely To Be a WomanWhile there has been much speculation on who will be nominated, court watchers have said Souter"s successor likely will be a woman, as the "lack of women [on the court] is widely perceived as the gap that most needs to be addressed," the Journal reports. Advocates for a female nominee argue that the need for a woman on the court is not only a matter of perception. Hannah Brenner, executive director of the University of Texas Center for Women in Law, said that the U.S. and the court benefit from justices with differing experiences and viewpoints. She added that "there is no one who can argue there is not (an) overwhelming number of qualified women who could be nominated to the court" (Forsyth, Wall Street Journal, 5/14).NPR"s "All Things Considered" reports that a list of potential nominees circulating in the public includes the following names: Sonia Sotomayor, a federal appeals judge in New York; Diane Wood of Chicago"s federal appeals court; Elena Kagan, the new solicitor general and former Harvard Law School dean; Michigan Gov. Jennifer Granholm (D); and Department of Homeland Security Secretary Janet Napolitano. Merrick Garland of the Washington, D.C., federal appeals court is the only male included on the list. The "triumvirate mentioned most often" is Sotomayor, Wood and Kagan, "All Things Considered" reports (Totenberg, "All Things Considered," NPR, 5/13).However, some critics -- namely conservatives -- say that there is danger in using gender or race as the primary criteria for selecting a nominee, arguing that such an approach could cause justices to believe they need to reflect the views of a particular group instead of act as a neutral figure. Stephen Presser, a legal historian at Northwestern University, said, "You have to be very careful of having the court be a representative body and thinking about it in political terms, because that weakens the rule of law." Deborah Rhode, director of the Center on the Legal Profession at Stanford University, said that studies show a justice"s legal ideology to be a greater predictor of decisions than his or
Cardiovascular

FDA Approves TYVASO (Treprostinil) Inhalation Solution For The Treatment Of Pulmonary Arterial Hypertension

United Therapeutics Corporation (Nasdaq: UTHR) announced that the United States Food and Drug Administration (FDA) has approved TYVASO (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the TYVASO Inhalation System (which includes the Optineb-ir device and accessories). TYVASO is indicated to increase walk distance in patients with NYHA Class III symptoms associated with WHO Group I PAH, which includes multiple etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease. "We are thrilled to have a fourth approval from the FDA for treatment of this serious cardio-pulmonary condition," said Martine Rothblatt, Ph.D., United Therapeutics" Chairman and Chief Executive Officer. "I want to specially recognize Drs. Werner Seeger of Germany and Lew Rubin of the United States for their critical pioneering efforts in making this new therapy possible. TYVASO epitomizes the hopes and dreams we had in forming this company." In connection with the TYVASO approval, United Therapeutics has agreed to Post-Marketing Commitments (PMC) to modify certain aspects of the TYVASO Inhalation System, perform a usability analysis and collect pharmacokinetic data to verify expected dosing with the modified device. "We are well underway with the modifications to the TYVASO Inhalation System," said Roger Jeffs, Ph.D., United Therapeutics" President and Chief Operating Officer, "And we think these modifications will make the device more patient-friendly. In the meantime, patients will use the current version of the device." We have committed to complete the PMC no later than October 31, 2010. Additionally, United Therapeutics has agreed to a Post-Marketing Requirement (PMR) to conduct a long-term observational study to evaluate the risk of oropharyngeal and pulmonary toxicities among patients using TYVASO. "We welcome the opportunity to gather further information on TYVASO"s safety," continued Dr. Jeffs. We have committed to complete the PMR no later than December 15, 2013. In the TRIUMPH-1 randomized, double-blind, 12-week placebo-controlled clinical trial, patients taking TYVASO in four daily inhalation sessions achieved a 20-meter improvement in six-minute walk distance over those taking placebo (p= 10%) seen with TYVASO in the placebo controlled clinical study were cough, headache, nausea, dizziness, flushing, throat irritation, pharyngolaryngeal pain and diarrhea. United Therapeutics plans to launch TYVASO in conjunction with its wholly-owned subsidiary, Lung Rx, Inc., in the United States at the beginning of September 2009. About TYVASO TYVASO is an inhaled medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature. TYVASO contains the same active ingredient (treprostinil) as REMODULIN (treprostinil sodium) Injection, which is also approved for the treatment of PAH. TYVASO is marketed by United Therapeutics and its wholly-owned subsidiary, Lung Rx, Inc. Nearly all clinical experience has been on a background of an endothelin receptor antagonist or a phosphodiesterase type 5 inhibitor. Important Safety Information for TYVASO TYVASO is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms, to increase walk distance. TYVASO is intended for oral inhalation only. TYVASO is approved for use only with the TYVASO Inhalation System. The safety and efficacy of TYVASO have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease). Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and any loss of drug effect. In patients with low systemic arterial pressure, TYVASO may cause symptomatic hypotension. TYVASO may also increase the risk of bleeding, particularly in patients receiving anticoagulants. The concomitant use of TYVASO with diuretics, antihypertensives or other vasodilators may increase the risk of systemic hypotension. Hepatic or renal insufficiency may increase exposure and decrease the tolerability of TYVASO. The most common side effects (>= 10%) seen with TYVASO in the placebo controlled clinical study were cough, headache, nausea, dizziness, flushing, throat irritation, pharyngolaryngeal pain and diarrhea. Please see the TYVASO full prescribing information or patient information for further details. About United Therapeutics United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer. Forward-looking Statements Statements included in this press release concerning, among others, the benefits of TYVASO for patients, our future activities to improve the TYVASO Inhalation System and its usability, our conducting a post-marketing usability analysis of the modified TYVASO Inhalation System device, the timing of completing the usability analysis, our conducting a post-marketing observational study of TYVASO, the timing of completing the observational study, and our plans to commercialize TYVASO in the United States are "forward-looking statements" within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and current reports on Form 8-K, which could cause actual results to differ materially from anticipated results. We are providing this information as of July 31, 2009, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. [uthr-g] REMODULIN is a registered trademark of United Therapeutics Corporation. TYVASO is a trademark of United Therapeutics Corporation. Optineb is a registered trademark of NEBU-TEC GmbH. United Therapeutics Corporation


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