Cell Therapy News Volume 9.42 | Oct 27 2008

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    Cell Therapy News 9.42, October 27, 2008
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Scientists Grow Mouse Prostate from a Single Cell: The four-person team at the Californian biotechnology firm Genentech said they achieved the feat after identifying a primitive, powerful cell called a stem cell in mouse prostates.
    Article

    Science

    Salk Researchers Successfully Reprogram Keratinocytes Attached to a Single Hair
    A team of researchers at the Salk Institute for Biological Studies, succeeded in boosting the reprogramming efficiency more than 100 fold, while cutting the time it takes in half over traditional methods.
    Article

    Caltech Engineers Build First-Ever Multi-Input “Plug-and-Play” Synthetic RNA Device
    Engineers from the California Institute of Technology have created a “plug-and-play” synthetic RNA device – a sort of eminently customizable biological computer – that is capable of taking in and responding to more than one biological or environmental signal at a time.
    Article

    University of Michigan Researchers Uncover New Links between Stem Cells, Aging and Cancer
    Four genes previously implicated in the control of cancer have been shown by University of Michigan scientists to play key roles in the aging process and stem-cell regulation.
    Article

    Living Cell Technologies Receives Health Minister’s Approval to Start Leading Edge Live Cell Therapy Clinical Trial in New Zealand for Diabetics
    Living Cell Technologies recently announced that the New Zealand Health Minister, has approved an application from the company to conduct in New Zealand a Phase I/IIa clinical trial of LCT’s lead product candidate for the treatment of insulin dependent (Type 1) diabetes.
    Article

    Late Problems Seen after Hodgkin’s Disease Therapy
    The chemotherapy, radiation, and stem cell therapy used to treat patients with relapsed or refractory Hodgkin’s disease are associated with significant long-term problems, including an increased risk of other cancers, according to a study in the Journal of Clinical Oncology.
    Article

    Spinal Cord Stem Cell Trial could Start Soon, Report Says
    A clinical trial that would test the use of embryonic stem cells to treat spinal cord injury could begin within three months thanks to a projected lifting of a Food and Drug Administration hold on the trial.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Promotion of Reprogramming to Ground State Pluripotency by Signal Inhibition
    The researchers report that brain-derived neural stem cells acquire undifferentiated morphology rapidly and at high frequency after a single round of transduction with reprogramming factors.
    Article

    Lentiviral-Mediated HoxB4 Expression in Human Embryonic Stem Cells Initiates Early Hematopoiesis in a Dose-Dependent Manner but does not Promote Myeloid Differentiation
    In this study, hESCs ectopically expressing high and low levels of HoxB4 were quantified throughout differentiation revealing a steady increase in transcription levels of the constructs.
    Article

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    Policy

    Britain Widens Scope for Stem Cell Research
    British plans to allow scientists to use hybrid animal-human embryos for stem cell research won final approval from lawmakers Wednesday in a sweeping overhaul of sensitive science laws.
    Article

    The United Kingdom and California Announce International Collaboration to Advance Stem Cell Research toward Cures
    The California Institute for Regenerative Medicine and the United Kingdom’s Medical Research Council announced recently an international collaboration on stem cell research.
    Article

    Stem Cell Science Experts Release Letter Urging U.S. Commitment to all Avenues of Stem Cell Research
    The International Society for Stem Cell Research joined with other leading scientists to issue an open letter to reiterate the urgent need for U.S. support for all types of stem cell research.
    Article

    Many Voters Admit to not Knowing Much about Stem Cells
    According to a report released recently, very few likely voters – 11 percent – feel that they know a lot about stem cell research. The good news: Voters do have an interest in learning more about stem cell research.
    Article

    Business

    Cellartis, Novo Nordisk and Lund University Enter into a Collaboration to Develop Insulin-Producing Cells from Stem Cells for the Treatment of Diabetes
    The collaboration aims to develop a cell therapy for the treatment of insulin-dependent diabetes and, in the longer term, a cure for diabetes.
    Article

    Stem Cell Research to Benefit Horse Owners and Trainers
    Melbourne scientists in collaboration with ViaGen Inc are hoping to develop equine embryonic stem cell lines, with the aim of creating a ‘bank’ of genetically matched stem cells preserved for individual horses.
    Article

    Roche Confirms Genentech Bid
    Swiss drug maker Roche Holding AG confirmed its commitment to a $43.7 billion bid for the rest of Genentech Inc.
    Article

    Biovest Announces $1.6M in Federal Funding Appropriated for Groundbreaking Cancer Vaccine & Skin/Bone/Tissue Repair Research
    Biovest International, Inc. recently announced that the U.S. Federal Government has approved the appropriation of $1.6 million in biomedical research funds for Fiscal Year 2009 for the Defense Department’s Cancer Immunotherapy and Cell Therapy Initiative.
    Article

    Biotechs Confront Bankruptcy as Funding Evaporates
    The biotechnology sector looks likely to be hit by a wave of bankruptcies and failures as small companies find themselves out of funding and out of options.
    Article

    CBER

    Cleared Biological 510(k) Device Applications – Update
    Link

    Approved Biological Premarket Approval (PMA) Device Applications – Update
    Link

    Approved Biological NDA and ANDA Applications – Update
    Link

    Substantially Equivalent 510(k) Device Information: Atreus Whole Blood Processing System 
    Link

    CBER Foreign Regulators Seminar
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States)

    HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America This Year
    The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008.
    Article

    Agency Information Collection Activities; Proposals, Submissions, and Approvals – Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format
    Link


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