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The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More
The Biosimilars Council is arguing that the federal law governing biosimilars does not grant branded biologics an extra six months of exclusivity. Read More
Amgen neglected to provide Genentech with information on its manufacturing process for an Avastin biosimilar, violating statutory requirements, Genentech contends in a complaint. Read More