News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Manufacturing issues surrounding low protein content in batches of Sandoz’ Neupogen copycat have been resolved ahead of an FDA review which could herald the first US biosimilar.
GSK cannot begin Phase II trials of its Ebola vaccine until February, while Merck & Co-NewLink’s Phase I study has restarted at a lower dose.
Flu vaccine maker Protein Sciences, and Japan-based UMN Pharma and IHI Corp. have entered into an agreement to assess the feasibility of sourcing the active ingredients of Flublok influenza vaccine from Japan.