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FDA 批准的新分子实体概述:1827-2013 年。

An overview of FDA-approved new molecular entities: 1827-2013.

机构信息

Yale Center for Molecular Discovery, Yale University, 600 West Campus Drive, West Haven, CT 06516, USA.

Yale Center for Molecular Discovery, Yale University, 600 West Campus Drive, West Haven, CT 06516, USA.

出版信息

Drug Discov Today. 2014 Aug;19(8):1033-9. doi: 10.1016/j.drudis.2014.03.018. Epub 2014 Mar 26.

DOI:10.1016/j.drudis.2014.03.018
PMID:24680947
Abstract

The pharmaceutical industry is undergoing fundamental change and its future is unclear. We performed a meta-analysis by cataloging FDA-approved legacy drugs and new molecular entities (NMEs). Objective information regarding scientific, medical and commercial activities was captured and provides insight into processes governing drug development. In this report, we review the rates of NME introduction through to the end of 2013. Recent trends show the emergence of a handful of companies that controls two-thirds of NMEs. We also report growth in the number of NMEs controlled by marketing organizations that have little or no internal drug discovery or development activities. This trend has increased dramatically since 2000 and could raise important questions about the future landscape and viability of drug discovery and development.

摘要

制药行业正在发生根本性变化,其未来前景尚不明朗。我们通过对美国食品和药物管理局批准的传统药物和新的分子实体(NME)进行编目,进行了一项荟萃分析。关于科学、医学和商业活动的客观信息被捕获,并深入了解了药物开发的过程。在本报告中,我们回顾了截至 2013 年底新的分子实体引入的速度。最近的趋势显示,少数几家公司控制了三分之二的新的分子实体。我们还报告了营销组织控制的新的分子实体数量的增长,这些组织几乎没有或没有内部药物发现或开发活动。自 2000 年以来,这一趋势急剧增加,这可能引发人们对药物发现和开发的未来格局和可行性的重要质疑。

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