2016 in review: FDA approvals of new molecular entities.

Abstract:

:An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms.

journal_name

Drug Discov Today

journal_title

Drug discovery today

authors

Griesenauer RH,Kinch MS

doi

10.1016/j.drudis.2017.06.011

subject

Has Abstract

pub_date

2017-11-01 00:00:00

pages

1593-1597

issue

11

eissn

1359-6446

issn

1878-5832

pii

S1359-6446(17)30129-0

journal_volume

22

pub_type

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