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Theratechnologies Updates Pre-License Inspection of Ibalizumab Manufacturing Facility
Aug. 03, 2017 09:16AM PST
Pharmaceutical InvestingTheratechnologies was notified of the US Food and Drug Administration completed a pre-license inspection of the WuXi Biologics facility where ibalizumab will be manufactured.
Theratechnologies (TSX:TH) was notified by their partner TaiMed Biologics that the US Food and Drug Administration completed the pre-license inspection of the WuXi Biologics facility where ibalizumab will be manufactured.
As quoted in the press release:
The inspection was carried out from July 17, 2017 to August 2, 2017. TaiMed has informed us that the FDA has finished the inspection with no critical findings. The FDA has made some observations and WuXi is committed to complete all follow-up actions as soon as possible, which is not expected to impact the review timelines of the ibalizumab Biologics License Application (BLA).
As a reminder, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2018, for the ibalizumab application.
The ibalizumab Expanded Access Program (EAP), or study TMB-311, is ongoing and enrolling patients. For more information about TMB-311 (NCT02707861), please refer to the ClinicalTrials.gov website (www.clinicaltrials.gov) or the study website (www.ibalizumab-eap.com).
Click here to read the full press release.
Source: www.marketwired.com
