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Genentech And Biogen Idec Submit Applications To The FDA For Rituxan For Most Common Type Of Adult Leukemia
Genentech, Inc. and Biogen Idec (Nasdaq:BIIB) announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan® (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL). The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.
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Gladstone Scientists Identify Genetic Factors That Hold Promise For Treatment Of Vascular Diseases
Researchers at the Gladstone Institute of Cardiovascular Disease (GICD) have discovered a key switch that makes stem cells turn into the type of muscle cells that reside in the wall of blood vessels. The same switch might be used in the future to limit growth of vascular muscle cells that cause narrowing of arteries leading to heart attacks and strokes, limit formation of blood vessels that feed cancers, or make new blood vessels for organs that are not getting enough blood flow.
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QRxPharma Initiates Comparative Phase 2 Proof-of-Concept Study For MoxDuo(TM) IV Pain Therapy
QRxPharma Limited (Pink Sheets: QRXPY; ASX: QRX) announced the initiation of a Phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of MoxDuo(TM) IV (intravenous morphine and oxycodone) versus IV morphine alone for the treatment of moderate to severe post-operative pain in patients following hip replacement surgery. Data from this study will serve as a significant predictor of MoxDuo(TM) IV"s clinical benefits and provide guidance for the design of further clinical trials leading to submission of an NDA to the US Food and Drug Administration (FDA) within the next three years.
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Ethics Review Of Research In The Context Of Humanitarian Relief Work

Two articles published this week in the open-access journal PLoS Medicine highlight the need for, and the practicalities of, getting appropriate ethical review of research done in the context of humanitarian relief. An article by Doris Schopper and colleagues describes the functioning of the Mç©decins Sans Frontiç¨res (MSF) independent ethics review board (ERB) and the framework used for ethics review by this board. The board, set up in 2001, currently comprises seven members from around the world, all independent of MSF. In 2008, the last full year of operation, the board reviewed 23 proposals covering a range of topic and study designs. As well as providing an overview the article describes some specific challenging ethical issues encountered by the board since its inception. In concluding the article, the authors say: "International humanitarian organizations such as MSF will be faced with even more complex health problems in the future as the global environment changes. Research to devise and test new interventions will remain an important part of MSF"s agenda, and will most probably increase. As this happens, a major concern will be to ensure that communities in which such research takes place are empowered to become true partners and that vulnerable individuals and groups are effectively protected The ethical oversight provided by the MSF ERB will be crucial in addressing these challenges." The editorial, written by the PLoS Medicine editors, discusses more generally the problems that can arise when research is done in such settings, and notes that ethical oversight of such research needs to be rigorous, but also pragmatic, and suggests what the role of journals should be. As the editorial notes, by supporting initiatives such as the MSF research ethics board, journals can help to address these ethical challenges, at the same time as ensuring that the research they publish adheres to accepted ethical standards. Article By Schopper and Colleagues: Funding: No funding was received for this work. Competing Interests: The authors have declared that no competing interests exist. Citation: "Research Ethics Review in Humanitarian Contexts: The Experience of the Independent Ethics Review Board of Medç©cins Sans Frontiç¨res." Schopper D, Upshur R, Matthys F, Singh JA, Bandewar SS, et al. (2009) PLoS Med 6(7): e1000115. doi:10.1371/journal.pmed.1000115 PLoS Medicine


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