News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Statisticians at the US Food and Drug Administration (FDA) said there was insufficient evidence to support the agency’s approval of the Alzheimer’s drug produced by Biogen, according to newly released internal memos.
Bio-Thera Solutions recently initiated a Phase 3 trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe, making it the first subcutaneous golimumab biosimilar to do so in multiple countries, according to a report from GlobalData.
Lonza will provide drug substance and product manufacturing for the biotech’s anti-IGF-1R antibody.
The company states that it will hire at least 155 new employees into manufacturing positions during 2021.