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The March Of Washingtons Distributes $30,000 For Antimalarial Drugs In Uganda
The March of Washingtons - the first broad-based campaign to increase access
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Kaiser Daily Health Policy Report Feature Highlights Recent Blog Entries
"Blog Watch" offers readers a roundup of health policy-related blog posts.The Congressional Budget Office is making waves: several bloggers are prognosticating about the agency"s forthcoming estimate of the cost of health reform proposals. The New Republic"s Jonathan Cohn reports that he"s hearing the cost estimate could be closer to $1 trillion than the previously discussed $1.5 trillion. However, Cohn notes that the figure does not include employer contributions and could still leave one-quarter to one-third of the uninsured without coverage. Cato"s Michael Cannon interprets last week"s announcement that several industry groups pledged to slow the growth of health care spending as evidence that the real motivation was "to pressure the Congressional Budget Office to assume that Democrats" health care reforms would reduce spending, despite the lack of evidence." (his emphasis) Bob Laszewski also hinted at this with a post titled "An Open Letter to the Men and Women Over at the CBO" that ended: "The only thing standing between BS reform and real reform are the men and women -- real men and real women -- over at the CBO ... Hang in there!!!!" Cannon echoes the sentiment with fewer exclamation points: "The CBO (and everybody else) should resist the Democrats" effort to make truth yield to power." Marginal Revolution"s Tyler Cowen says he"s reviewing "health care cost fallacies" and asks readers to "sign on to" this statement: "The fiscal outlook is grimmer than before, therefore we should spend less on health care reform than I used to think." Ezra Klein, from his new perch at the Washington Post, counters with his own: "The fiscal outlook is grimmer than before, therefore we should agree on more radical health reforms than were previously considered." Klein then links to a Center for Economic and Policy Research graph, which shows the projected deficit as a proportion of the gross domestic product for various industrialized nations. Unsurprisingly, the line for the United States is headed skyward, while those for Canada, France, Germany and England drop. Meanwhile, disputes continue on a public plan option. Families USA President Ron Pollack reminds readers of his support: "As I said last week at the Senate Finance Committtee"s roundtable. ... First, a public plan option would increase choice. Second, it creates a benchmark on cost that is likely to have a positive impact on lowering costs on private plans. Third, the public plan would be a of obtaining important data about health care that is unlikely available through the private plans, and will enable certain improvements in America"s health care system." Yet Jeff Goldsmith on the Health Affairs Blog says that such a plan is "not worth the risks" and advises, "Health reformers would be smart to trade the radioactive "public plan" bargaining chip for concessions from the industry and to focus their attention on finding an employment-friendly financing plan, and on Medicare payment reform." The National Journal"s Marilyn Werber Serafini solicits her experts" opinions: Are we any closer to consensus on a public health plan after Senate Finance Committee Chair Max Baucus (D-Mont.) and ranking member Chuck Grassley (R-Iowa) presented three options for the committee to consider as part of broader health care reform legislation this year? The responders -- Stuart Butler, Karen Davis, Marian Wright Edelman, Uwe Reinhardt and John Sheils -- don"t come to a conclusion. Interesting elsewhere:
News of the day
Phase III Study Showed Lucentis Improved Vision In Patients With Branch Retinal Vein Occlusion
Genentech, Inc. announced that the Phase III study BRAVO showed Lucentis® (ranibizumab injection) improved vision, as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity at six months, in patients with macular edema due to branch retinal vein occlusion. The safety profile of Lucentis was consistent with previous experience and no new adverse events related to Lucentis were observed in the study. Retinal vein occlusion (RVO) is a common cause of vision loss that occurs when blood flow through a retinal vein becomes blocked, such as by a blood clot.
Cardiovascular

NeurogesX Announces New PDUFA Date For Qutenza(TM) New Drug Application

NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date from August 16, 2009 to November 16, 2009 to review the new drug application (NDA) for Qutenza(TM) to manage pain associated with postherpetic neuralgia (PHN). The extension resulted from the Company"s recent submission of data requested by the agency late in the review cycle, which the FDA has classified as a major NDA amendment. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline. Anthony DiTonno, President and CEO, commented, "The FDA"s three-month extension is not unexpected. We previously discussed the potential for this extension as a result of our responses to FDA requests for additional information. The information we submitted in July included the report from our recently completed C123 Study, which was performed at the request of the FDA. We believe that with this updated review timeline, if we gain approval in November, we may still achieve our overall goal of launching Qutenza in the United States in the first half of 2010." About NeurogesX, Inc. NeurogesX (NASDAQ: NGSX) is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX" late stage product portfolio is led by its product candidate Qutenza(TM), a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions. Qutenza is currently approved in the European Union for the treatment of neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. Qutenza will be marketed in the European Union and certain countries in Eastern Europe, the Middle East and Africa, by Astellas Pharma Europe, Ltd. In the United States, NeurogesX submitted a new drug application (NDA) for PHN to the U.S. Food and Drug Administration (FDA) which was accepted for filing by the FDA in December 2008 and has been given an extended Prescription Drug User Fee Act (PDUFA) date of November 16, 2009. NeurogesX" second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 has completed three Phase 1 studies and NeurogesX is currently evaluating the design and timing of further development efforts. NeurogesX" early stage product pipeline includes pre-clinical compounds, which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is currently seeking development partners for these programs. Safe Harbor Statement This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that may be obtained with respect to the NDA for Qutenza with the FDA, including the PDUFA date for the NDA; acceptance of clinical trial or other data, analysis or information by the FDA in support of regulatory approval; plans and timing for commercialization of Qutenza; outcomes and interpretation of the results of clinical trials; and plans for entry into a U.S. commercialization partnership, including the timing with respect to entry into such a partnership. Such statements are based on management"s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to; positive results in clinical trials may not be sufficient to obtain FDA approval; the FDA may request additional clinical trials or other information prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to certain indications; NeurogesX" product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy or tolerability; physician or patient reluctance to use Qutenza or NGX-1998, if approved; and other difficulties or delays in, clinical development of, and obtaining regulatory approval for NeurogesX" product candidates. For further information regarding these and other risks related to NeurogesX" business, investors should consult NeurogesX" filings with the Securities and Exchange Commission. NeurogesX, Inc


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