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China has released details of a pilot program that extends drug product licensing to domestic research and development institutions and their personnel. Read More
Even with an abundance of FDA work left undone with biosimilars, industry development activities seem unaffected, with many “extremely active” in that space, an agency official says. 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
The House and Senate conferees met Wednesday to mark up the Comprehensive Addiction and Recovery Act, making a few changes but leaving intact two critical elements related to opioid approval and FDA oversight. Read More