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FDA approval of the UroLift System marks a significant milestone for NeoTract and brings a truly minimally invasive treatment option to the millions of men suffering from BPH in the US.� We have been very impressed with the thorough and efficient De Novo review process conducted by the FDA, said Dave Amerson, President and CEO of NeoTract, Inc. We believe UroLift is a first line treatment option for patients with BPH given its strong therapeutic benefit and safety profile. For more information on Data-driven Trial Execution, please visit <a rel=nofollow href=https://mail.ubm-us.com/owa/redir.aspx?C=ba0XlS7pGUWwPGsa5ILR-qQPZOr5s9AIvSVk-xsZmj8PRWgmBZYWN435D6SFLTjwMkVAG40Fkhc.&URL=http%3a%2f%2fwww.quintiles.com%2fdatadriventrialexecution target=_blank>www.quintiles.com/datadriventrialexecution</a> or register to attend Quintiles� November 15 webinar, entitled �<a rel=nofollow href=https://mail.ubm-us.com/owa/redir.aspx?C=ba0XlS7pGUWwPGsa5ILR-qQPZOr5s9AIvSVk-xsZmj8PRWgmBZYWN435D6SFLTjwMkVAG40Fkhc.&URL=http%3a%2f%2fxtalks.com%2fnext-generation-of-risk-based-monitoring.ashx target=_blank>Data-driven Trial Execution: Delivering Next-generation Risk-based Monitoring</a>,� led by Dan White, vice president of Global Operations at Quintiles. If we ever hope to understand how the microbiome [community of microbes] affects health and how environmental interactions alter it, we have to expand research to cover different populations, study author Jordan Peccia, associate professor of environmental engineering at Yale University, said in a journal news release.

The FDA team also flagged inadequate separation between the area where the drugs were mixed and the common pharmacy area, quality control problems, and non-compliance with standard operating procedure. The rats involved in the study were infected with <i>E. coli</i> and other bacteria and toxins that are similar to human bloodstream infections. The researchers found that roughly 90 percent of the bacteria and toxins were removed from the rats' blood after five hours of filtering. While 90 percent of the treated rats survived, 14 percent of those in an untreated control group did not. The increased risk applies to children of all ages, researchers said. Their advice: Parents and doctors should help children lose excess weight now to prevent high blood pressure from affecting them as adults. DSP has set the Oncology area as the focus therapeutic area in addition to the Psychiatry & Neurology and channels all energies into innovative drug discovery. To serve this area of very high unmet medical needs, the Company has established an integrated global R&D system comprising the DSP Cancer Institute and Boston Biomedical, Inc., one of its key U.S. subsidiaries. The Oncology Clinical Development Unit is created as a unit specialized in the oncology area within the Company�s Drug Development Division with a view to strengthening oncology-related clinical development in Japan.

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