News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week.
The World Health Organisation says a meeting between drugmakers and high-level government representatives last week has yielded plans to fast-track scale-up of Ebola vaccines in the face of incomplete trials and leaked production problems.
Bristol-Myers Squibb (B-MS) and Lonza on Thursday announced a multi-year expansion of their existing biologics manufacturing agreement.