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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.
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.
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.
Here, the authors highlight how there are considerable similarities in the disease mechanisms and pathogenic pathways involved in Huntington's disease and Alzheimer's disease, and advocate that these shared mechanisms could be exploited as common therapeutic targets for drug development.
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.