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Re: jbog post# 204448

Monday, 10/17/2016 9:45:10 AM

Monday, October 17, 2016 9:45:10 AM

Post# of 251689
FDA clinical hold on REGN/TEVA phase-2b Fasinumab (NGF) trial in back pain:

http://finance.yahoo.com/news/regeneron-teva-fasinumab-clinical-development-110000723.html

The U.S. Food and Drug Administration (FDA) has placed the Phase 2b study in chronic low back pain on clinical hold and requested an amendment of the study protocol after observing a case of adjudicated arthropathy in a patient receiving high dose fasinumab who had advanced osteoarthritis at study entry. As a result of the FDA decision, Regeneron completed an unplanned interim review of results and has stopped dosing in the study.

To date, NGF has not exactly been an enterprising target for drug/biotech companies to pursue.

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