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  • Regulatory NewsRegulatory News

    EMA Recommends Two Amgen Humira Biosimilars

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended eight medicines for approval, including two Amgen biosimilars for AbbVie’s blockbuster Humira (adalimumab). Amgevita and Solymbic are the first adalimumab biosimilars recommended for approval in the EU. Humira was first authorized in the EU on 8 September 2003. The EMA recommendations were announced on the same day AbbVie announced Humira sales of $16 ...
  • Pfizer's Tofacitinib Wins Regulatory Approval Ahead of PDUFA Date

    • 07 November 2012
    After a lengthy back and forth, Pfizer's potential rheumatoid arthritis blockbuster Xeljanz (tofacatinib) has won approval from the US Food and Drug Administration (FDA), the agency announced on 6 November. Rheumatoid arthritis (RA) is a disease in which the body's immune system attacks otherwise healthy tissue, causing joint and tissue swelling and damage. Xeljanz is expected to fill a large niche market for patients with RA who did not respond to methotrexate, also...
  • Blockbuster Asthma Drug Singulair Receives Generic Competition

    Generic versions of Merck's pharmaceutical blockbuster Singulair (montelukast sodium) are now available to consumers, making it the latest product to fall off the so-called 'patent cliff,' the US Food and Drug Administration (FDA) announced on 3 August . The drug is used by asthma and allergy sufferers to reduce inflammation, and was Merck's most lucrative, bringing in sales of up to $5 billion per year . The company is expected to lose much of its market share to its ...