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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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TB Booster Vaccine Trials To Begin Next Month In South Africa
A new two-year trial to test a tuberculosis vaccine aimed at boosting the efficacy of the BCG vaccine is scheduled to begin soon in South Africa, IRIN reports (IRIN, 6/4). The vaccine candidate, called MVA85A, will be tested next month in 2,874 children younger than age one. The new tests will be the "first concept trial of a new preventative TB vaccine for infants in close to 90 years," according to Reuters.
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ANA Responds To Recent Negative Portrayals Of TV Nurses Who Violate Nursing Code Of Ethics

At a time when the entertainment industry is perpetuating inaccurate portrayals of nursing in the new television shows "Nurse Jackie" and "HawthoRNe," ANA"s ethics books are especially relevant to all registered nurses (RNs). The fictional nurses are shown violating the nursing Code of Ethics by participating in activities ranging from on-the-job drug use to inappropriate nurse/patient contact in these shows. The very heart of nursing is mischaracterized as nurses are portrayed engaging in irresponsible and often criminal acts for entertainment purposes. ANA sets the ethical standards for nurses in the U.S. and internationally with its highly respected Code of Ethics for Nurses with Interpretive Statements, and is deeply concerned about the lasting impact these negative portrayals may have on the nursing profession. "Ethics are integral to the foundation of nursing, and nurses are proud and passionate advocates for the delivery of dignified, humane health care. We have received many e-mails and letters from nurses expressing their outrage at these flawed TV depictions of nursing, the most trusted and ethical of professions," said ANA President Rebecca M. Patton, MSN, RN, CNOR. "Nurses take ANA"s Code of Ethics seriously. These harmful portrayals violate the basic, sacred trust that nurses have with their patients and may dissuade young people from choosing to become nurses, at a time when a national nursing shortage is looming and res are stretched thin." As a result of the high standards set forth in ANA"s Code of Ethics, the nursing profession consistently ranks as the most trusted in the country today. The first nursing code of ethics was the "Florence Nightingale Pledge," which has served as the basis for numerous Hollywood portrayals of nurses, and continues to be administered at nursing school graduations to this day. ANA has done extensive work in the area of health care ethics, recently publishing three books that will provide a framework for ethical decision making in all areas of nursing practice ( Guide to the Code of Ethics for Nurses: Interpretation and Application; Nursing and Health Care Ethics: A Legacy and A Vision ; and Genetics and Ethics in Healthcare: New Questions in the Age of Genomic Health). ANA


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