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EU


While Brivaracetam is being evaluated as an adjunctive therapy in patients diagnosed with Epilepsy and partial onset seizures, animal models have piqued the curiosity of R&D experts as to Brivaracetam being a potential treatment for Alzheimer’s patients. As a unique product with a high-affinity synaptic vesicle protein 2A ligand, Brivaracetam is currently marketed by UCB,[…]

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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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Regorafenib is a formidable treatment for colon cancer, and in late 2013 it has received another new approval for GIST in Japan and Europe. Known as the trade name Stivarga, Regorafenib was approved in both Japan and Europe for the treatment of gastrointestinal stromal tumors. The FDA approved Regorafenib two years ago and added 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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The Regorafenib tablet gains EU approval for the treatment of metastasized colorectal cancer (mCRC) in adults, whose disease has progressed even after treatment with standard drugs. Regorafenib was previously approved by the FDA in late May 2012 to treat patients with metastatic colorectal cancer. That initial approval of Regorafenib for unresectable colon cancer was based on the[…]

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Rilpivirine is a non-nucleoside reverse transcriptase inhibitor {NTRI} known as the brand name Edurant. Rilpivirine is used to treat HIV-1 infection, and it is often dispensed alongside other antiretroviral agents. As a 25 milligram tablet designed to be taken once daily with food, rilpivirine is effective at decreasing the amount of HIV infection in the[…]

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