The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables. / read more /
Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework. / read more /
Novartis will partner with MorphoSys and Galapagos to develop and commercialize their joint investigational, fully human, IgG1 monoclonal antibody (mAb) directed against the target IL-17C. / read more /
The acquisition would combine Sangamo's ex vivo gene-editing capabilities with TxCell's regulatory T-cell (Treg) expertise to create chimeric antigen receptor (CAR)-Treg therapies. / read more /
The API and drug product provider will invest £375,000 (US$493,000) in additional nuclear magnetic resonance (NMR) instrumentation at its headquarters in Craigavon, UK. / read more /
The glass and chemical provider will expand its synthetic pharmaceutical intermediate and API production capacity at its plant in Chiba, Japan. / read more /
This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
