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U.S. Marshals Seize Drug Products Manufactured By Caraco Pharmaceutical Laboratories Ltd. FDA Acts To Prevent Repeated Drug Quality Problems
U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company"s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, M.D., director of the FDA"s Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public."
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Pfizer Announces New Phase 1 Data From Two Novel Compounds For Alzheimer's Disease At ICAD Annual Meeting
Pfizer Inc announced today results from two Phase 1 safety studies, one of PF-04360365, a humanized anti-amyloid monoclonal antibody (mAb), and another of dimebon (latrepirdine*) in combination with donepezil HCl tablets, in patients with Alzheimer"s disease.1,2 Based on the Phase 1 study results, PF-04360365 has advanced into Phase 2.3 Dimebon (latrepirdine), being co-developed by Pfizer and Medivation Inc., is in Phase 3 development.4 These data were presented this week at the Alzheimer"s Association 2009 International Conference on Alzheimer"s Disease (ICAD) in Vienna, Austria.
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Secrets Of Addiction Revealed By Drug-Proof Zebrafish
The effects of amphetamines on gene expression in zebrafish have been uncovered. This new study, published in BioMed Central"s open access journal Genome Biology, provides clues to the genetics that underlie susceptibility to addiction by describing the nad zebrafish mutant, which does not feel the rewarding effects of the drugs.
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EmblemHealth Provides New Medical Manual To Help Clinicians Address Religio-Cultural Issues That Influence Health Care Decisions

To meet the needs of its diverse clinician and patient constituency, EmblemHealth announced on Friday publication of what is believed to be the first comprehensive guide to help physicians and medical professionals address the needs of patients whose health care decisions are influenced by their religious and cultural beliefs. The Medical Manual for Religio-Cultural Competency is sponsored by EmblemHealth and created by the Tanenbaum Center For Interreligious Understanding, a global leader in training health care providers to offer religiously and culturally competent care for patients of all ages and backgrounds. "We believe this is the first publication to address the role of religion in medical care in such a comprehensive and concrete way," says Dr. William A. Gillespie, SVP and Chief Medical Officer of EmblemHealth. "It supports our efforts to address disparities in care and barriers to access by improving and enhancing communication between practitioners and patients." According to one study, 41 percent of those who responded said they make health care-related decisions for themselves or their loved ones based on religious beliefs while 83 percent want their health care providers to ask about their religious needs. Only nine percent actually reported having been asked. [Annals of Family Medicine (2004) 2(4): 356-361] The 230-page Medical Manual was researched and written by Tanenbaum professionals with expertise in religious diversity and how it relates to health care, and vetted by outside medical and religious experts. It allows health care professionals to quickly locate information on specific religious traditions and practices, including nutrition and diet, modesty and dress, pain management, birth, organ donation, and palliative care. It includes additional res for those who want to learn more. Religious traditions covered are Judaism, Christianity, Islam, Buddhism, Hinduism, Sikhism, Shinto, Traditional Chinese, American Indian & Alaska Natives and Afro-Caribbean. "Publication of this manual on the religious and cultural issues that influence health care decisions is part of our ongoing commitment to leadership in innovative health care practices that are relevant to today"s needs," Dr. Gillespie adds, noting that New Jersey already requires physicians to undergo "cultural-competency training" in order to obtain and renew a license by the State Board of Medical Examiners. He says similar legislation has been introduced in other states, including New York, and that EmblemHealth is looking at ways to offer CME credits for its physicians. Through its affiliated companies, HIP Health Plan of NY and GHI Group Health Incorporated, EmblemHealth serves a diverse population of members, physicians and other providers in New York City and the tristate area. EmblemHealth targeted providers in New York"s most diverse counties, offering nearly 6,000 of them an opportunity to reserve a free copy of The Medical Manual. In addition, all EmblemHealth practitioners will be able to log on to EmblemHealth"s website to download a copy, also free of charge. Tanenbaum plans to make The Medical Manual available to health care organizations and medical professionals nationwide following EmblemHealth"s release. Tanenbaum and EmblemHealth"s Integrative Wellness Department agreed that The Medical Manual was a much-needed re to enhance EmblemHealth"s efforts to address the stated needs of its practitioners. EmblemHealth surveys indicated physicians" desire for res addressing religious diversity and cultural issues in medical practice, leading to their sponsorship of Tanenbaum to research and write the manual. "We"re proud that EmblemHealth turned to us to develop this groundbreaking re," says Joyce S. Dubensky, Executive Director & CEO of Tanenbaum, a secular non-profit organization based in New York that has extensive experience designing practical tools to help navigate sensitive interreligious issues. "Tanenbaum"s expertise in helping medical professionals become more alert to the role religion and culture plays in health care outcomes complemented EmblemHealth"s desire to provide res to improve the quality of care. We were able to leverage our years of experience and to harness our and EmblemHealth"s relationships with key leaders to produce a first-of-its-kind re that can change how health care is provided." EmblemHealth


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