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Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) For The Treatment Of Fabry Disease
Amicus Therapeutics (Nasdaq: FOLD) announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease. The Company has reached agreement with the U.S. Food and Drug Administration (FDA) on the key protocol design elements of the pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the Company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations. The Company has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of this year.
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New Online Tool Maps HIV, AIDS Prevalence By County, Other Statistics
The National Minority Quality Forum (NMQF) today launched an online tool that maps the prevalence of HIV and AIDS by county, age, gender and ethnicity in all 50 states, Washington, D.C., Puerto Rico and the U.S. Virgin Islands, the San Francisco Chronicle reports. The HIV/AIDS Atlas is based on 2006 data collected from states and cross-checked with CDC data. The NMQF partnered with George Washington University"s School of Public Health and Health Services to collect and analyze the data. Gary Puckrein, chief executive officer of NMQF, said the new tool will help improve data collection and analysis, prevention initiatives, early diagnosis and routine testing efforts in areas most affected by HIV/AIDS (Colliver, San Francisco Chronicle, 6/21).
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Australian Medical Association To Work With Government On Nurse Legislation
The Australian Medical Association will work with the Federal Government to ensure patients benefit from the introduction of new prescribing rights for nurse practitioners and midwives.
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New Data Supports Significant Economic And Clinical Value Of MENOPUR(R) In IVF

New data from an economic analysis presented today at this year"s European Society of Human Reproduction and Embryology (ESHRE) congress showed that, within the parameters of the simulation model used, the in vitro fertilisation (IVF) treatment MENOPUR (highly-purified human menopausal gonatropin or HP-hMG) offered considerable cost-savings over recombinant follicle stimulating hormone (rFSH).1 The cost-effectiveness of HP-hMG compared with rFSH suggested by this data could make it a more attractive choice for use in infertility treatment within a fixed healthcare budget. In today"s difficult global financial situation, the cost-effectiveness of infertility treatments, such as IVF, is more important than ever. Experiencing fertility problems is deeply distressing and isolating for couples and the cost of treatment is one of many considerations for people seeking treatment. A recent audit of European infertility patient groups showed that infertile couples are calling for clear information on the cost-effectiveness, as well as the efficacy of individual treatments.2 HP-hMG and rFSH are two commonly used hormonal therapies belonging to the class of drugs known as gonadotropins that enhance egg production in IVF treatment. HP-hMG, contains both FSH and hCG-driven (human chorionic gonadotropin) LH-activity (luteinizing hormone). In contrast, rFSH is a recombinant product and contains only rFSH. "Until recently, discussions regarding funding for infertility treatment services have been hindered by a relative paucity of economic studies of the specific treatments," points out study investigator Dr Jaro Wex from PharmArchitecture, UK. "Our new study compared success rates and value for money of gonadotropins in IVF and this work is likely to have a major impact on the decision-making process with respect to IVF treatment. The study showed that HP-hMG is a more attractive option than rFSH within a fixed budget, as it offers considerable cost savings over rFSH, not only in terms of costs per treatment cycle, but also in costs per live births." Health economic data The new study determined the cost-effectiveness of different gonadotropins in IVF cycles involving frozen embryo transfers using a simulation model. The economic evaluation compared HP-hMG and rFSH using individual patient data (n=986) pooled from two large, randomised, multi-national, non-inferiority trials (EISG3 and MERiT4)5. The simulation model used both live-birth data for the compared products and published UK costs of IVF related medical res. The main objectives were to determine for each patient starting treatment consisting of one fresh and up to two cryo or fresh cycles: (1) number of live-births (2) average cost of treatment; (3) average cost per live-birth; (4) incremental cost-effectiveness; (5) impact of inclusion of maternal and neonatal costs arising from successful pregnancies. After a sequence of one fresh and up to two frozen or fresh cycles, the cumulative live-birth rate was 53.7% for HP-hMG and 44.6% for rFSH (pMENOPUR MENOPUR belongs to a class of drugs known as gonadotropins and contains both FSH (follicle stimulating hormone) and hCG-driven (human chorionic gonadotropin) LH-activity (luteinizing hormone). HP-hMG is used to stimulate the development of multiple follicles in women participating in an ART programme. HP-hMG is also used to treat infertility in women caused by anovulation (low-level production of eggs). MENOPUR is used by over 75,000 patients each year and is currently licensed in over 50 countries across the world Ferring Pharmaceuticals


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