Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.
The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.
The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.
The US FDA has issued warning letters to two API makers found to have deviated from cGMP: Germany’s BBT Biotech and China’s Tai Heng Industry.
Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.
An API plant operated by Dhanuka Laboratories does not comply with good manufacturing practices according to Croatian regulators.