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Weblog met nieuws over de pharmaceutische industrie

Archive for May, 2009

GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA(TM) (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.
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  • Bayer Healthcare Pharmaceuticals Inc. announced that several studies evaluating the use of Leukine(R) (sargramostim) will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting. “We are excited to see that several studies of Leukine have been accepted at ASCO,” said Pam Cyrus, MD, vice president, Medical Affairs, Oncology, Bayer HealthCare Pharmaceuticals.
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  • VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced that an analysis of clinical data of its lead anticancer agent Onrigin (laromustine) Injection in acute myeloid leukemia (AML) would be presented in a poster at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida.
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  • Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) announced top-line results from its U.S. Phase II clinical trial to treat cocaine addiction. The data from the trial showed that CPP-109 did not demonstrate statistical significance in the primary endpoint — that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 11 and 12).
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  • Perceptive Informatics, the industry’s leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (Nasdaq: PRXL), announced the launch of a website designed to help investigators apply the new 1.1 version of RECIST (Response Evaluation Criteria In Solid Tumors) in medical imaging-based oncology trials.
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  • CuraGen Corporation (Nasdaq: CRGN) announced plans for three data presentations from its ongoing clinical trials of CR011-vcMMAE, an antibody-drug conjugate that targets GPNMB, in patients with advanced breast cancer and melanoma at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida.
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  • GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab
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  • Informa Healthcare - one of the world’s leading medical and scientific publishers- has announced that its peer-reviewed medical titles will be joining the company’s pharmaceutical science titles to form one, united platform for drug discovery and clinical medicine on http://www.Informahealthcare.com.
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  • Researchers at the University of California, San Francisco, and collaborators at Harvard Medical School have linked a specialized protein in human muscles to the process that clears glucose out of the bloodstream, shedding light on what goes wrong in type 2 diabetes on a cellular level.
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  • MIT and Boston University engineers have designed cells that can count and “remember” cellular events, using simple circuits in which a series of genes are activated in a specific order. Such circuits, which mimic those found on computer chips, could be used to count the number of times a cell divides, or to study a sequence of developmental stages. They could also serve as biosensors that count exposures to different toxins.
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