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

Tue, 05/13/2014 - 3:58pm

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 . The report provides a full list of medications in development by the major pharmaceutical companies and their stage in the development process.



Share this Story

You may login with either your assigned username or your e-mail address.
The password field is case sensitive.