2016 in review: FDA approvals of new molecular entities

Rebekah H. Griesenauer, Michael S. Kinch

Research output: Contribution to journalShort surveypeer-review

10 Scopus citations

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.

Original languageEnglish
Pages (from-to)1593-1597
Number of pages5
JournalDrug Discovery Today
Volume22
Issue number11
DOIs
StatePublished - Nov 2017

Fingerprint Dive into the research topics of '2016 in review: FDA approvals of new molecular entities'. Together they form a unique fingerprint.

Cite this