Biotech, and bioprocessing more specifically, is a great place to be. But it's time for a new adventure.
China's regulators acknowledge the quality gap, and have a plan for steady improvement.
Industry and regulators disagree over noncritical parameters.
Good leaders look beyond industry woes to focus on patients
Amgen has issued Epogen and Procrit recall.
Regulators, Industry Disagree Over Noncritical Process Parameters at CMC Forum
The third holy grail of biosimilars: interchangeability.
ImClone, a subsidiary of Eli Lilly, has closed a manufacturing facility at its site in Branchburg, NJ, as originally reported by MyCentralJersey.com and confirmed by BioPharm International.
Regulatory relief requires that regulators trust companies to know what they are doing, and to do it—consistently.