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  • Regulatory NewsRegulatory News

    FDA Panel Unanimously Backs Amgen’s Humira Biosimilar

    The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee on Tuesday voted unanimously to support Amgen’s biosimilar for AbbVie’s blockbuster biologic Humira (adalimumab). The vote – 26-0, with no abstentions – followed the release of a positive review from FDA staff, and came after a lot of discussion on whether the data presented by Amgen could be extrapolated to all of the indications that Humira is approved for, as well as questions on analytical ch...
  • FDA Panel Recommends Restarting Testing of Controversial Pain Drugs

    An US Food and Drug Administration (FDA) Advisory Committee Panel recommended clinical trials testing anti-nerve growth factor inhibitors (anti-NGF inhibitors) be allowed to continue, with certain precautions, reports The Associated Press. The Arthritis Advisory Committee (AAC) voted 21-0 on 12 March to recommend that research continue in light of the unmet needs of patients. Panelists noted many patients do not respond to existing pain medications such as aspirin a...