Jefferies Reiterates Buy on Amgen (AMGN) Following FDA Approval of Humira Biosimilar
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Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab
July 12, 2016 7:30 AM EDTTHOUSAND OAKS, Calif., July 12, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira® (adalimumab), an anti-tumor necrosis factor-alpha (TNF-) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.
During the meeting, Amgen will present a comprehensive data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from... More
FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor
July 11, 2016 9:02 AM EDTTHOUSAND OAKS, Calif., July 11, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.1 The Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from... More
