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WHO Approves HPV Vaccine Cervarix For Use In Developing Countries
The World Health Organization has approved GlaxoSmithKline"s human papillomavirus vaccine Cervarix, thus enabling United Nations agencies and partners to officially purchase millions of doses for use in low-income nations, the AP/San Diego Union-Tribune reports (AP/San Diego Union-Tribune, 7/9). Cervarix is highly effective at preventing HPV types 16 and 18, which cause about 70% of cervical cancer cases (GSK release, 7/9). According to the AP/Union-Tribune, more than 80% of the estimated 280,000 cervical cancer deaths annually occur in developing countries.Cervarix has not been approved for use in the U.S. and Japan, but it is available in 97 other countries. FDA is expected to decide in the next few months whether to approve Cervarix for use in the U.S. (AP/San Diego Union-Tribune, 7/9). The agency in 2006 approved Merck"s HPV vaccine Gardasil for girls and women ages nine to 26. Centers for Disease Control and Prevention guidelines recommend routine three-dose vaccination for girls ages 11 and 12 and for girls and women ages 13 to 26 who have not yet been vaccinated (CDC fact sheet, June 2008).The three-shot regimen typically costs about $360. It is unclear if GSK will provide Cervarix at a lower cost to U.N. agencies purchasing it for developing countries (AP/San Diego Union-Tribune, 7/9). GSK said that it is "eager to work with our long-term partner GAVI as well as other private [non-governmental organizations] or governments of developing countries to identify financing mechanisms for the vaccine" (Stovall, Dow Jones, 7/9). The global health association GAVI is a major buyer of vaccines for the developing world. In 2008, GAVI prioritized the purchase of HPV vaccines for the world"s 73 poorest nations. The organization includes U.N. agencies, the World Bank and the Bill and Melinda Gates Foundation (AP/San Diego Union-Tribune, 7/9).

European Medicines Agency Recommends First Marketing Authorisation For Cell-Based Medicine That Repairs Femoral Condyle Cartilage Defects
The European Medicines Agency has recommended the first marketing
News of the day
PPD Confirms Takeda Receives FDA Complete Response For Alogliptin
PPD, Inc. (NASDAQ: PPDI) today announced that Takeda Pharmaceutical Company Limited issued a news release reporting that Takeda Global Research & Development Center, Inc., its wholly-owned U.S. subsidiary, has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for alogliptin.
Cardiovascular

States Confront Budget Pressure, Anticipate Reform

States are grappling with budget cuts, trying to anticipate the effects of Washington"s health system overhaul and rejiggering Medicaid programs. Here"s a round-up of today"s local coverage: Boston Globe: "A unique state program that helps pay most health insurance costs for 27,000 unemployed Massachusetts residents is on the cusp of going broke, setting off a debate between healthcare advocates and business leaders who say funding it is a burden on companies fighting for their survival." The program is financed by taxes; officials who oversee the program are expected to hike taxes to make up shortfalls in November (Lazar, 8/5). Idaho Statesman: "The state will buy all required childhood vaccines for all Idaho children through January 2010, whether their families have health insurance or not, Gov. Butch Otter announced Tuesday." The move comes after the state health department announced that insured children would no longer receive the free vaccines due to budget cuts. The governor said the plan is not a "long-term solution," and said he hopes the legislation will come up with one (LaMay, 8/4). The Tennessean: A new law will allow Tennessee"s Medicaid managed care program, TennCare, to pursue small fraud cases - those totaling less than $10,000 - with administrative law judges. The change is expected to free up the state"s attorney general for larger cases (Ward, 8/5). The Salt Lake (Utah) Tribune: "Health care reform, if it succeeds, may result in thousands more Utahns getting health insurance. But in a state already strapped for doctors, it doesn"t mean they will get to see a physician right away" (Rosetta, 8/4). Health News Florida: "About 1 million Medicaid patients, mostly children, were wrongly dropped from the August eligibility rolls over the weekend because of a computer glitch, the Agency for Health Care Administration has confirmed" (Gentry, 8/4). This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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