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TMCNet:  Fitch: U.S. Pharmaceutical Approvals Decline Significantly with Mixed Outlook for R&D

[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 28.6 approvals.

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 process.

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

http://www.fitchratings.com/creditdesk/reports/report_frame.cfm?rpt_id=748020

ALL FITCH CREDIT RATINGS ARE SUBJECT TO CERTAIN LIMITATIONS AND DISCLAIMERS. PLEASE READ THESE LIMITATIONS AND DISCLAIMERS BY FOLLOWING THIS LINK: HTTP://FITCHRATINGS.COM/UNDERSTANDINGCREDITRATINGS. IN ADDITION, RATING DEFINITIONS AND THE TERMS OF USE OF SUCH RATINGS ARE AVAILABLE ON (News - Alert) THE AGENCY'S PUBLIC WEBSITE 'WWW.FITCHRATINGS.COM'. PUBLISHED RATINGS, CRITERIA AND METHODOLOGIES ARE AVAILABLE FROM THIS SITE AT ALL TIMES. FITCH'S CODE OF CONDUCT, CONFIDENTIALITY, CONFLICTS OF INTEREST, AFFILIATE FIREWALL, COMPLIANCE AND OTHER RELEVANT POLICIES AND PROCEDURES ARE ALSO AVAILABLE FROM THE 'CODE OF CONDUCT' SECTION OF THIS SITE. FITCH MAY HAVE PROVIDED ANOTHER PERMISSIBLE SERVICE TO THE RATED ENTITY OR ITS RELATED THIRD PARTIES. DETAILS OF THIS SERVICE FOR RATINGS FOR WHICH THE LEAD ANALYST IS BASED IN AN EU-REGISTERED ENTITY CAN BE FOUND ON THE ENTITY SUMMARY PAGE FOR THIS ISSUER ON THE FITCH WEBSITE.


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