News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
GlaxoSmithKline plc (GSK) says the US Food and Drug Administration (FDA) has approved its anti-IL-5 biologic Nucala (mepolizumab) in a 40 mg pre-filled syringe for children aged 6 to 11 years old with severe eosinophilic asthma (SEA).
The construction of Yposkesi’s second facility is on track, the French CDMO has confirmed.
Biotech EdiGene has announced an R&D collaboration with Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and platform technology.
Pfizer and BioNTech expect to produce four billion doses of their COVID-19 vaccine in 2022: regardless of whether the current vaccine or a new Omicron specific vaccine is needed.