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EPA Announces Public Health Emergency In Libby, Montana
U.S. Environmental Protection Agency Administrator Lisa P. Jackson announced the agency has determined that a public health emergency exists at the Libby asbestos site in northwest Montana. Over the past years, hundreds of asbestos-related disease cases have been documented in this small community, which covers the towns of Libby and Troy. The announcement was made today at a joint press conference with Department of Health and Human Services Secretary Kathleen Sebelius and U.S. Sens. Max Baucus and Jon Tester.
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SPECT MPI With Cardiolite(R) Used In BARI 2D Study To Evaluate Type 2 Diabetes And Coronary Artery Disease Treatment Strategies
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, announced today that the company"s leading imaging agent, Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), was used in a recently completed five-year study examining appropriate treatment regimens for patients with type 2 diabetes and coronary artery disease. The results of this study, known as The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D), will be presented by the University of Pittsburgh Graduate School of Public Health at a special symposium on Sunday, June 7, 2009, from 4:15 p.m. - 5:15 p.m. (CT) at the American Diabetes Association 69th Scientific Sessions in New Orleans.
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Biogen Idec Receives Fast Track Designation From FDA For PEGylated Interferon Beta-1a For Relapsing Multiple Sclerosis
Biogen Idec (NASDAQ: BIIB) announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.
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Regulatory Affairs Professionals Society (RAPS) Opens RAPS Europe In Brussels

The Regulatory Affairs Professionals Society (RAPS), the world"s largest international membership organization of regulatory professionals in the medical device, pharmaceutical, and biotechnology sectors, announced the opening of its European office in Brussels. RAPS Europe will support RAPS programs, events and operations throughout Europe and serve as the organization"s base for European operations. RAPS, which is headquartered near Washington, DC, USA, also opened an office in Tokyo last year. The growing internationalization of the healthcare product sector is driving increased global involvement among regulatory professionals. According to RAPS" own research, about 70% of regulatory professionals say their work encompasses regulatory issues in multiple geographic regions. "RAPS" membership includes healthcare product regulatory professionals all over the world, including many in Europe," said RAPS Executive Director Sherry Keramidas, PhD, CAE. "RAPS" new office in Brussels allows us to better serve our European members and be more responsive to their needs, as well as more closely track trends at both EU and individual country levels. It also will enable us to support additional efforts to reach out to and serve the entire European regulatory community with relevant RAPS products and services." Additionally, RAPS is planning more European events. RAPS will hold two programs in June covering EU regulatory essentials -- one in Brussels (http://www.raps.org/eubrussels) and one in Vienna ( http://www.raps.org/euvienna) -- and a workshop in Brussels in November covering US submissions and compliance. RAPS also will explore more opportunities to help Europe-based professionals learn about and prepare for Regulatory Affairs Certification (RAC). The RAC is the only professional certification specifically for those in the healthcare regulatory field and continues to be highly valued in the international regulatory community. RAPS has contracted with Interel, an association management and public affairs firm, which will provide operational and communications support for RAPS Europe in Brussels. RAPS Europe will be located at 22-24 Rue du Luxembourg, B-1000 Brussels, Belgium; and can be reached at rapseurope@raps.org. Regulatory Affairs Professionals Society (RAPS)


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