TaiMed and AcedrA officially signed an exclusive license, commercialization, and distribution agreement for Trogarzo in the MENA region.
Trogarzo® IM maintenance dosing aims to further enhance the convenience of non-oral therapy for heavily treatment-experienced adults with HIV Submission comes on the heels of the recent FDA approval...
Theratechnologies` Biologic Trogarzo (ibalizumab) Receives Approval in the U.S.
Theratechnologies' Biologic Trogarzo (Ibalizumab uiyk) Receives Approval in the U.S.
MONTREAL, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the United States Food and Drug Administration (FDA) approved Trogarzo® (ibalizumab-uiyk) for administration by intravenous (IV) push, a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation. In the U.S., Trogarzo®, in combination with other antiretrovirals (ARVs), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant virus failing their current ARV regimen.
MONTREAL, July 06, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that data presented at the 23rd International AIDS Conference virtual meeting, demonstrates that ibalizumab is active in vitro against group A and group B HIV-2.
Vaccine producer Seqirus says for the 2019-2020 flu season, it will manufacture vaccines for all four flu strains recommended by WHO using its cell-based processes. Release
WuXi Biologics a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, has received EMA GMP certificates for the production of Trogarzo™ at its cGMP Drug Substance (DS) and Drug Product (DP) manufacturing facilities in Wuxi city and its cGMP cell banking facilities in Shanghai. Trogarzo™ is developed by TaiMed Biologics and marketed in the U.S. and EU by Theratechnologies.
WuXi Biologics announced that the European Medicines Agency (EMA) has completed the Pre-Approval Inspection (PAI) of the company’s cGMP Drug Substance (DS) and Drug Product (DP) manufacturing facilities for the production of TaiMed Biologics’ Trogarzo with no critical findings. WuXi Biologics will submit responses to the EMA inspection report in March 2019 and expects to obtain GMP certification for its facilities in May 2019.