Friday, January 3, 2020 Daily Archives

China Oks first CDMO-made MAb since Drug Administration law revision

China has approved tislelizumab, a drug for Hodgkin’s lymphoma developed by BeiGene and made locally by Boehringer Ingelheim. The monoclonal antibody (Mab) is the first biopharmaceutical approved under China’s recently modified Drug Administration Law (DAL). The law was revised in August introducing a marketing authorization holder (MAH) system similar to those in the US and EU. The revision also formalized rules governing contract manufacturing. Previously, regulatory approvals were contingent on the developer having its own manufacturing capacity in China. However, in 2015 the…

How process optimization brought Bivigam back to the market

ADMA Biologics says a data driven approach was key to bringing its primary immune deficiency disease drug Bivigam back to market. Bivigam (Immune Globulin Intravenous [Human], 10% Liquid) relaunched in the US in August, roughly three years after it was pulled from pharmacy shelves by then owner, Biotest Pharmaceuticals Corporation. Biotest withdrew Bivigam in late 2016 after a US FDA inspection team uncovered “multiple manufacturing inconsistencies and control issues†at its facility in Boca Raton, Florida. ADMA bought Biotest in…