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Cephalon Submits NUVIGIL Supplemental New Drug Application For The Treatment Of Excessive Sleepiness Associated With Jet Lag Disorder
Cephalon, Inc. (Nasdaq: CEPH) announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Jet lag disorder is an acute condition that occurs when a person"s internal body clock becomes disrupted as a result of rapid travel across several time zones. Based on U.S. Bureau of Labor Statistics findings, an estimated 70 million American travelers experience jet lag annually. Currently, there are no FDA-approved medications to improve wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights.
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VIA Pharmaceuticals Meets With FDA To Discuss Next Steps For VIA-2291 And Phase 3 Outcome Trial In Cardiovascular Disease
VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, announced today that an end of Phase 2a meeting for the Company"s lead drug, VIA-2291 (atreleuton), was recently held with the U.S. Food and Drug Administration (FDA). The Company reviewed safety and biologic activity data from the VIA-2291 Phase 2 CEA and ACS trials with the FDA and received guidance including suggestions from the Agency on the Company"s Phase 3 trial design.
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Warning Issued Over Proposed Drug Company Promotion Of Medicines To Public, UK
Drug companies may exploit new rules to promote their products to the public but present it as mere provision of information, according to an editorial published this week in the Drug and Therapeutics Bulletin (DTB).
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Internists Note 'Close Alignment' With Policies In America's Affordable Health Choices Act Of 2009

The president of the American College of Physicians (ACP) told the chairmen of the House Ways and Means, Energy and Commerce, and Education and Labor Committees that America"s Affordable Health Choices Act of 2009, H.R. 3200, is "closely aligned" with ACP policies on coverage, workforce, and payment and delivery system reform. Writing on behalf of ACP, the second largest physician membership organization in the U.S., with 129,000 internal physician and medical student members, President Joseph W. Stubbs, MD, FACP, noted that America"s Affordable Health Choices Act of 2009 "includes policies on coverage, workforce, payment and delivery system reform, primary care, comparative effectiveness research, and administrative simplification that are strongly supported by the College." He urged approval of the bill by the three House committees of jurisdiction. Dr. Stubbs said that ACP also "expects" to recommend passage of the legislation by the full House of Representatives, pending review of amendments to the bill that may be made by the committees. On coverage, Dr. Stubbs noted ACP"s support for sliding scale tax credits to help people buy coverage through a health exchange and reforms to require that health insurers cover people with pre-existing conditions at affordable rates. He expressed strong support for requiring that all insurers cover preventive services and other essential benefits Dr. Stubbs applauded the bill"s policies to ensure a sufficient supply of primary care physicians, including new and expanded programs to provide scholarships and loan forgiveness for physicians who elect to go into a primary care specialty and serve in areas of need. On payment and delivery system reform, Dr. Stubbs expressed appreciation for the bill"s elimination of scheduled Medicare physician fee schedule cuts-and the accumulated budget cost associated with such cuts-- caused by the flawed Medicare SGR formula; replacing the SGR with new targets that will provide for higher baseline spending targets and updates for evaluation and management and preventive services; increased payments to primary care physicians; and dedicated funding to pilot test patient-centered medical homes on a national scale. Dr. Stubbs stated that ACP is committed to doing all it can to get legislation enacted this year to ensure that all Americans will have access to affordable coverage and to a general internist or other primary care physician. He concluded by saying, "We believe that America"s Affordable Health Choices Act of 2009, H.R. 3200, will go a very long way toward achieving ACP"s goals [for health care reform] and we look forward to its being favorably reported out of the three committees." The American College of Physicians


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