Tag Archives: biomarkers

Challenges to the Specialty Business Model

By Emily O’Connor, Jillian Scaife, and Ryan P. Million Biopharmaceutical drug discovery companies have progressively tailored their pipelines to specialty therapeutic areas and smaller patient populations. However, the specialty business model has lately shown signs of strain and outright constraints in continued scalability. Agents such as Gleevec, Zaltrap, and Sovaldi have been under fire from […]
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Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
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Woodcock Urges Forward March Toward Personalized Medicine

New approaches for conducting clinical trials and developing therapies that actually prevent and cure disease are key to the future of effective drug therapy, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). Personalized medicine has achieved mainstream status, accounting for more new drug approvals and promising pipeline candidates, […]
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