TY - JOUR
T1 - 2016 in review
T2 - FDA approvals of new molecular entities
AU - Griesenauer, Rebekah H.
AU - Kinch, Michael S.
N1 - Publisher Copyright:
© 2017 Elsevier Ltd
PY - 2017/11
Y1 - 2017/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85022213980&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2017.06.011
DO - 10.1016/j.drudis.2017.06.011
M3 - Short survey
C2 - 28687460
AN - SCOPUS:85022213980
SN - 1359-6446
VL - 22
SP - 1593
EP - 1597
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 11
ER -