TY - JOUR
T1 - 2018 in review
T2 - FDA approvals of new molecular entities
AU - Kinch, Michael S.
AU - Griesenauer, Rebekah H.
N1 - Funding Information:
Research reported in this publication was supported by the Washington University Institute of Clinical and Translational Sciences grant UL1TR002345 , subaward TL1TR002344, from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official view of the NIH.
Funding Information:
Research reported in this publication was supported by the Washington University Institute of Clinical and Translational Sciences grant UL1TR002345, subaward TL1TR002344, from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official view of the NIH.
Publisher Copyright:
© 2019
PY - 2019/9
Y1 - 2019/9
N2 - 2018 was a remarkable year, both in terms of the number of new molecular entities (NMEs) approved and the organizations developing them. In total, 59 NMEs received a nod from the US Food and Drug Administration (FDA), most of which were approved using a priority or breakthrough designation. Orphan drugs accounted for more than half of new approvals, only the second time in history that level has been achieved. Moreover, the net number of organizations that received an FDA approval and remain active in new drug research surged in 2018, reflecting both an increase in new organizations and lower levels of industry consolidation.
AB - 2018 was a remarkable year, both in terms of the number of new molecular entities (NMEs) approved and the organizations developing them. In total, 59 NMEs received a nod from the US Food and Drug Administration (FDA), most of which were approved using a priority or breakthrough designation. Orphan drugs accounted for more than half of new approvals, only the second time in history that level has been achieved. Moreover, the net number of organizations that received an FDA approval and remain active in new drug research surged in 2018, reflecting both an increase in new organizations and lower levels of industry consolidation.
UR - http://www.scopus.com/inward/record.url?scp=85066921981&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2019.05.022
DO - 10.1016/j.drudis.2019.05.022
M3 - Short survey
C2 - 31158510
AN - SCOPUS:85066921981
SN - 1359-6446
VL - 24
SP - 1710
EP - 1714
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 9
ER -