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TaiMed HIV-1 drug manufacturing facility clears US FDA pre-license inspection

The U.S. Food and Drug Administration completed the pre-license inspection of the WuXi Biologics Inc. facility, where TaiMed Biologics Inc.'s ibalizumab will be manufactured.

The regulator carried out the inspection from July 17 to Aug. 2 and made some observations that are not expected to impact the review timelines of the ibalizumab biologics license application.

Theratechnologies Inc. recently secured the commercial rights to ibalizumab in Israel, Norway, Russia, Switzerland and the EU. The company already owns the rights to the HIV-1 drug in the U.S. and Canada.

TaiMed Biologics said that WuXi Biologics, which is an affiliate of China-based WuXi AppTec, said it was committed to complete all follow-up actions as soon as possible.