Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · Sep 2013
The PCAST report on pharmaceutical innovation: implications for the FDA.
In September 2012, the President's Council of Advisors on Science and Technology (PCAST) released the report "Propelling Innovation in Drug Discovery, Development and Evaluation." A product of discussions with many stakeholders, the report reiterates current problems in drug development, including diminished return on basic biomedical research. The report calls for doubling the current annual output of innovative new medicines--an ambitious goal. Recommendations and resulting initiatives will probably affect the FDA's drug regulatory programs.
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The landscape for bioinnovation is undergoing a seismic shift as drug developers, regulators, academic institutions, and government research organizations adapt to the formidable challenge of bringing new medicines to market. The inability to translate current advances in the scientific understanding of disease into new therapeutics is forcing all sectors to replace traditional drug development paradigms with newer and more efficient models. This issue of Clinical Pharmacology & Therapeutics explores these changes to the bioinnovation ecosystem.
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Clin. Pharmacol. Ther. · Sep 2013
ReviewIndustry and regulatory performance in 2012: a year in review.
2012 was a robust year for new molecular entity (NME) approvals in the major geographic regions. What is behind this apparent improved performance? Has the pharmaceutical industry turned the tide in research and development productivity? In this analysis, we look not only at the number of approvals in 2012 but also at their clinical and market potential. We discuss how changes in the regulatory and reimbursement environment impact current industry performance and how this might evolve.
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Pharmaceutical innovation is often measured by counting the new drugs approved by regulators. It is a simple and useful metric, but it has shortcomings. ⋯ This article aims to provide it by analyzing the drugs approved by the US Food and Drug Administration between 2000 and 2012. It examines their modes of action, highlights key trends, and discusses their implications for our ability to generate innovation.