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EU Approved 2014


The early EU approval for Ibrutinib was granted by the European Commission (EC), for Ibrutinib to be sold in the 28 European Union (EU) member states. Ibrutinib is a first-in-class, oral, once-daily, non-chemotherapy treatment option, and will be used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).[…]

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Bristol-Myers Squibb and Pfizer has announced that the European Commission has approved Apixaban (Eliquis) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults. There is an estimated 600,000 people affected by DVT/PE each year in the U.S., and almost 100,000 of those people die[…]

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The EU approved the formidable drug Tocilizumab, also known as the brand name RoACTEMRA, which is marketed by Roche Pharmaceuticals, at the end of April 2014. As the only FDA approved medication for treating systemic JIA and polyarticular JIA in children, Tocilizumab is well regarded in the United States. Tocilizumab is approved by both the[…]

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The end of March 2014 brought exciting news from the EU with the announcement of their approval of Cabozantinib for unresectable medullary thyroid carcinoma. Known as the brand name Cometriq and marketed by Exelixis, Cabozantinib works by inhibiting the activity of MET, RET and VEGFR tyrosine kinases. Cases of medullary thyroid carcinoma are virulent and[…]

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UPDATE: On May 6, 2014, Propranolol was approved by the European Commission for treatment of infantile hemangioma. Infantile hemangioma, or an overgrowth of blood vessels on or under the skin of infants is a benign vascular condition. As a common non-life threatening tumor of the skin, infantile hemangioma occur during the first four weeks of[…]

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Dimethyl Fumarate was approved by the EU at the beginning of February 2014 as a first line treatment for multiple sclerosis. Known as the brand name TECFIDERA, which is marketed by Biogen Inc., this efficacious and novel treatment is specified for patients with the most common form of multiple sclerosis, relapsing-remitting multiple sclerosis, or RRMS.[…]

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On January 24, 2014 the European Commission announced their marketing authorization to both AstraZeneca and Bristol-Myers Squibb for Xigduo. As a powerful medication for type 2 diabetes, Xigduo is a combination of Dapagliflozin and Metformin Hydrochloride, and available in two dosages: 5mg/850mg and 5mg/1,000mg tablets, respectively. This dynamic duo of powerhouse anti-diabetic medications is designed[…]

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