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Volume 10 Issue 11, November 2011

In This Issue

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Comment

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News and Analysis

  • An eventful year — including panel meetings, approvals and a refusal to file a new drug application — has sharpened the focus around the FDA's requirements for accelerated approval of anticancer drugs.

    • Asher Mullard
    News and Analysis
  • Promising Phase II data and a flurry of deal-making indicate that bispecific platform technologies are about to take antibodies to the next level.

    • David Holmes
    News and Analysis
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News in Brief

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Biobusiness Briefs

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Patent Watch

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An Audience With

  • David Urdal, Chief Scientific Officer at Dendreon, discusses his 30-year experience in industry ahead of his retirement later this year.

    An Audience With
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From the Analyst's Couch

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Fresh from the Pipeline

    • Keith. T Flaherty
    • Uma Yasothan
    • Peter Kirkpatrick
    Fresh from the Pipeline
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Research Highlight

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In Brief

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Analysis

  • Co-developing a drug with a diagnostic to create a stratified medicine — a therapy that is targeted to a specific patient population on the basis of a clinical biomarker — presents challenges for product developers, regulators, payers and physicians. With the aim of developing a shared framework and tools for addressing these challenges, this article presents an analysis using data from case studies in oncology and Alzheimer's disease, coupled with integrated computational modelling of clinical outcomes and economic value, to quantify the effects of decisions on key issues such as the design of clinical trials.

    • Mark R. Trusheim
    • Breon Burgess
    • Michael C. Palmer
    Analysis
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Review Article

  • Although traditionally exploited to improve anticancer drug delivery, the potential uses of nanomedicine in the management of cardiovascular disease are now recognized. Here, Mulder and colleagues review recent advances in applying nanotechnology to the diagnosis and treatment of atherosclerosis.

    • Mark E. Lobatto
    • Valentin Fuster
    • Willem J. M. Mulder
    Review Article
  • Mammalian target of rapamycin (mTOR) has a central role in controlling cellular growth and metabolism. Hall and colleagues describe the advances in therapeutic targeting of this protein, and discuss their potential for the treatment of cancer and beyond.

    • Don Benjamin
    • Marco Colombi
    • Michael N. Hall
    Review Article
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