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FDA places Regeneron and Teva's pain-drug study on hold
2016年10月17日 / 中午11点32分 / 1 年前

FDA places Regeneron and Teva's pain-drug study on hold

Oct 17 (Reuters) - Regeneron Pharmaceuticals Inc and partner Teva Pharmaceutical Industries Ltd said the U.S. health regulator has placed a clinical hold on a mid-stage study of their experimental drug for chronic lower back pain.

The Food and Drug Administration (FDA) imposed the hold after observing a case of a type of joint inflammation in an advanced osteoarthritis patient, who was given a high dose of the drug, fasinumab.

Following the FDA decision, Regeneron has completed an unplanned interim review of data and has stopped dosing patients, the company said on Monday.

Fasinumab is also in development for use in osteoarthritis pain. (Reporting by Natalie Grover in Bengaluru; Editing by Anil D‘Silva)

我们的标准:汤森路透“信任原则”
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