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  • EMA Publishes New Lupus Guideline Intended to Spur Development of New Therapies

    The European Medicines Agency (EMA) has published a new guideline on medicines for the treatment of lupus, its first on the topic. Lupus erythematous (LE) is a chronic auto-immune inflammatory disease that manifests itself in either cutaneous (CLE) or systemic (SLE) form In a statement released on 5 March 2013, EMA explained that while advancements in care have dramatically reduce mortalities and morbidities associated with the disease, "Many patients still have incompl...
  • Citing a Change in Thinking, FDA Withdraws Lupus Product Guidance

    The US Food and Drug Administration (FDA) said it is withdrawing a guidance document published in June 2010 in light of the document no longer reflecting its current thinking on the topic. In its 26 June 2012 Federal Register posting, FDA said its guidance, " Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing Medical Products for Treatment ," was being withdrawn immediately. Systemic Lupus Erythamatosus is an autoimmune disease in which the body's immun...