Kinch Michael S
Center for Research Innovation in Business, Washington University in St Louis, St Louis, MO 63110, USA.
Drug Discov Today. 2017 Apr;22(4):620-624. doi: 10.1016/j.drudis.2015.06.004. Epub 2015 Jun 19.
The year 2014 witnessed the approval by the US Food and Drug Administration (FDA) of 42 new molecular entities (NMEs), which is well above recent averages. These molecules targeted a range of molecular pathways and clinical indications, although the latter was skewed toward hepatitis C virus (HCV) infection and diabetes. By contrast, a single drug was approved for cardiovascular diseases and none for neurological indications (excepting sleeping disorders). Of note is a continued trend toward consolidation because the net number of biotechnology companies has reached its lowest point in over 25 years, raising questions about sustainability.
2014年，美国食品药品监督管理局（FDA）批准了42种新分子实体（NMEs），这一数字远高于近期平均水平。这些分子针对一系列分子途径和临床适应症，不过临床适应症偏向丙型肝炎病毒（HCV）感染和糖尿病。相比之下，仅有一种药物获批用于心血管疾病，而获批用于神经适应症的药物则无一（睡眠障碍除外）。值得注意的是，合并的趋势仍在持续，因为生物技术公司的净数量已降至25年多以来的最低点，这引发了对可持续性的质疑。
