|[May 13, 2014]
Fitch: U.S. Pharmaceutical Approvals Decline Significantly with Mixed Outlook for R&D
CHICAGO --(Business Wire)--
The number of U.S. pharmaceutical approvals continued to decline in the
first quarter of 2014 (1Q'14), with the outlook for research and
development (R&D) mixed for the remainder of the year, according to a
Fitch Ratings report.
The FDA approved six new molecular entities (NMEs) during 1Q'14 compared
with nine approvals in the prior year period. This is the lowest number
of approvals in a quarter since before 2000. The FDA cleared 27 novel
medicines for U.S. marketing during 2013 in comparison to 37 in 2012.
The five-year average at the end of 2013, however, was approximately
On the positive side, several pharmaceutical companies have increased
activity in the oncological segment, a move Fitch views as constructive,
since some combination-therapy approaches may lead to more effective
cancer treatment paradigms.
Fitch's full 'Global Pharmaceutical R&D Pipeline' is available at 'www.fitchratings.com'.
The report provides a full list of medications in development by the
major harmaceutical companies and their stage in the development
Additional information is available at 'www.fitchratings.com'.
Applicable Criteria and Related Research: Global Pharmaceutical R&D
Pipeline - Evolving Trends in Diabetes and Cancer Treatments
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