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Smear Tests For Under 25s Have Little Impact On Cancer Rates
Cervical screening in women aged 20-24 has little or no impact on rates of invasive cervical cancer up to age 30, concludes a study published on bmj.com.
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PIH Founder Farmer Discussing Possible Appointment To Coordinate U.S. Global Health Initiatives, Boston Globe Reports
Paul Farmer -- founder of Partners in Health and vice chair of the Department of Global Health and Social Medicine at Harvard Medical School -- said he is in discussions with the State Department about a possible Obama administration appointment to coordinate U.S. global health initiatives, the Boston Globe reports. Farmer made the announcement Monday during a meeting with HMS faculty. Farmer said that he has not decided whether he will accept the appointment if he receives a formal offer but that he is considering it, according to the Globe. The Globe reports that it was unable to confirm whether Farmer is being considered for a full-time policy position or for an advisory role or if the appointment would be a new or existing position. Several top positions at USAID -- including administrator, deputy administrator and the assistant administrator in charge of global health are vacant, the Globe reports. These positions are presidential appointments and would require Senate confirmation. In addition, Farmer could be discussing health policy positions with the State Department. Farmer did not respond for requests seeking comment. PIH and HMS also declined comment. A spokesperson at the State Department would not discuss personnel discussions that are in progress or possible new positions. Laurie Garrett, a global health policy specialist at the Council on Foreign Relations, said the administration"s announcement last week of a $63 billion, six-year initiative that aims to address HIV/AIDS, tuberculosis, malaria and other illnesses could allow new appointees the opportunity to make a significant impact in U.S. global health policy. Garrett, who has known Farmer for several years, added that she would be surprised if he is considering a government position in part because of his extensive involvement with PIH (Smith, Boston Globe, 5/15).
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University Of Michigan Study Shows SEQUENOM's MassARRAY Technology Identifies HPV Infections Missed By Standard Hybridization Test
Results from a study published by the University of Michigan have shown that as many as 15% of women in the study group determined to be negative for the presence of human papillomavirus (HPV) in the cervix, via the most commonly used test for HPV DNA, may actually be infected with the virus at clinically relevant viral loads. PCR-MS detected the presence of high-risk HPV in nearly half (46.7%) of women who tested negative by the Hybrid Capture 2 (HC2) test, which is standard of care in many countries. Approximately 9,000 American women are diagnosed with cervical cancer each year despite regular cervical screening. The study, titled, Development and Evaluation of a PCR and Mass Spectroscopy-based (PCR-MS) Method for Quantitative, Type-specific Detection of Human Papillomavirus, will be published in the September 2009 edition of Journal of Virological Methods. The assay used in this study is exclusively licensed by SEQUENOM (Nasdaq: SQNM).
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A.P. Pharma Submits New Drug Application For APF530 In Chemotherapy-Induced Nausea And Vomiting

A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, announced that it has submitted a New Drug Application (NDA) for its lead product, APF530, to the U.S. Food and Drug Administration (FDA). APF530 is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) and is a long-acting formulation of granisetron that utilizes the Company"s proprietary Biochronomer™ drug delivery system. "The submission of this NDA marks a significant milestone for the APF530 program, our Biochronomer™ drug delivery technology and A.P. Pharma as a company," said Ronald J. Prentki, A.P. Pharma"s president and chief executive officer. "Our number-one priority has been to assemble and submit a complete and high-quality NDA. We thank our regulatory, CMC, clinical and e-filing experts for their tireless efforts and look forward to a timely review by the FDA." "The favorable efficacy and safety demonstrated in the APF530 Phase 3 clinical program provides a strong foundation for our submission," stated Mr. Prentki. "We believe APF530, which maintains therapeutic drug levels for five days, will be a "long acting" agent offering important advantages over anti-emetics currently used in the prevention of CINV, and would provide a particular benefit to those many patients suffering with delayed onset nausea and vomiting." The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA"s prior safety and efficacy findings for APF530"s active ingredient, granisetron. The FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the Company of its determination within fourteen days thereafter. If the NDA is accepted for filing, under the Prescription Drug User Fee Act guidelines, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following NDA submission. About APF530 A.P. Pharma"s lead product candidate, APF530, is being developed for the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron, formulated in our proprietary Biochronomer™ drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Injections and oral tablets containing granisetron are approved for the prevention of acute onset CINV, but not for delayed onset CINV. Granisetron was selected because it is widely prescribed by physicians based on a well-established record of safety and efficacy. In September 2008, A.P. Pharma reported positive top-line results from its pivotal Phase 3 study. In this multi-center, randomized trial that enrolled 1,395 cancer patients, APF530 was shown to be equally as effective as (statistically non-inferior to) palonosetron (Aloxi®) in the prevention of both acute onset and delayed onset CINV. Palonosetron is the only injectable 5-HT3 antagonist FDA-approved for the prevention of delayed onset CINV. APF530 was also generally well-tolerated in this study. About CINV Prevention and control of nausea and vomiting, or emesis, are very important in the treatment of cancer patients. The majority of patients receiving chemotherapy will experience some degree of emesis if not prevented with an anti-emetic, typically administered just prior to chemotherapy. Chemotherapy treatments can be classified as moderately emetogenic, meaning that 30% to 90% of patients experience CINV, or highly emetogenic, meaning that more than 90% of patients experience CINV, if they do not receive an anti-emetic. Acute onset CINV occurs within the first 24 hours following chemotherapy treatment. Delayed onset CINV occurs more than 24 hours after treatment and may persist for several days. Prevention of CINV is important because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to delay or discontinue chemotherapy. A.P. Pharma


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