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Generic trade groups and patient advocacy organizations are taking competing stances in their recommendations for the FDA’s biosimilar labeling draft guidance. Read More
China has released details of a pilot program that extends drug product licensing to domestic research and development institutions and their personnel. Read More
The patent dispute over Janssen’s Remicade continues to balloon, with the drugmaker suing GE Healthcare subsidiary HyClone Laboratories over the use of cell cultures to grow a biosimilar of the drug. Read More
A new study of oncology approvals shows a majority of the candidates approved under accelerated review with surrogate endpoints lacked validation. Read More