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Viiv Healthcare Ltd., late Thursday, won FDA approval for Rukobia (fostemsavir), a gp120-directed attachment inhibitor for the treatment of adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The drug was reviewed under FDA's fast track and breakthrough therapy status programs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Adial, Ascendis, CSL Behring, Daiichi Sankyo, Esperare Foundation, Gilead, Medivir, Mesoblast, Mylan, Napo, Sinovac, Viiv.
CAJICA, Colombia – The Latin American biotech sector is scrambling in the midst of the COVID-19 pandemic, not only in coping with the outbreak, but also in finding the path to the future, while avoiding the pitfalls and looking for new opportunities ahead.
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acacia, Beigene, Biophytis Eusa, Geron, Metvital, Mundipharma, Napp, Rhythm.
Biosimilars referencing Amgen Inc.’s rheumatoid arthritis drug, Enbrel (etanercept), could remain sidelined in the U.S. for nearly another decade, following a Federal Circuit decision Wednesday affirming the validity of two patents protecting etanercept and its manufacturing methods.
The U.S. Department of Veterans Affairs (VA) is looking for more discounts from prescription drug manufacturers, but it likely will be a few years before the ask becomes reality as it will require congressional action and federal rulemaking.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian, Blueprint, EMD, Golden, Hangzhou Yuyuan, Isa, Janssen, Medicinova, Mezzion, Pfizer, Revive, Rhythm, Scpharmaceuticals, Sun, TC, Obseva, Ultragenyx, Y-mabs.
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