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  • Amgen's Aranesp Target of OPDP Letter, Agency's Seventh in as Many Weeks

    Biopharmaceutical manufacturer Amgen is the latest company to receive an Untitled Letter from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), the latest in a flurry of letters sent by the office in recent weeks regarding allegedly deficient marketing practices. The 19 November 2013 letter to Amgen, made public on 22 November, references a direct mailer used by the company to market its anemia drug Aranesp (darbepoetin alfa). Regu...
  • Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit

    • 12 June 2012
    The Supreme Court of the United States (SCOTUS) said it agreed to hear a challenge from life sciences manufacturer Amgen regarding a lawsuit alleging the company inflated its stock price by misleading investors about the safety of its anemia drugs, Aranesp and Epogen. Amgen is reportedly contesting the class-action nature of the lawsuit, which it says could have the perverse effect of placing severe financial pressures on companies if allowed to stand. "At issue," expla...