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FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA

Michele B. Kaufman, PharmD, BCGP  |  June 9, 2017


Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

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  1. Hirschler B. Heart safety clouds hopes for Amgen, UCB bone drug. Reuters. 2017 May 23.
  2. Amgen Inc. News release: Amgen and UCB announce top-line phase 3 data from active-comparator study of Evenity (romosozumab) in postmenopausal women with osteoporosis. 2017 May 21.
  3. Roche. News release: FDA grants priority review for Roche’s Actemra/RoActemra (tocilizumab) supplemental biologics license application for giant cell arteritis, a form of vasculitis. 2017 Jan 24.
  4. Genentech Inc. News release: FDA approves Genentech’s Actemra (tocilizumab) for giant cell arteritis. 2017 May 22.

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Filed under:Biologics/DMARDsConditionsDrug UpdatesOsteoarthritis and Bone Disorders Tagged with:FDAFood and Drug AdministrationFracturesgiant cell arteritis (GCA)heartOsteoporosisromosozumabside effecttocilizumab

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