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News Breaks
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November 30, 2009
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| 09:04 EDT |  | BMRN |
| theflyonthewall.com: | BioMarin receives orphan drug designation for 3,4-DAP for LEMS | | BioMarin Pharmaceutical announced that the FDA has granted orphan drug designation for 3,4-diaminopyridine, amifampridine phosphate, for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome. 3,4-DAP has previously received orphan drug designation in the E.U. Also, in October 2009, the Committee for Medicinal Products for Human Use of the European Medicines Evaluations Agency adopted a positive opinion recommending approval of amifampridine phosphate for LEMS. If approved by the European Commission, amifampridine phosphate will be the first approved treatment for LEMS, thereby conferring orphan drug protection and providing ten years of market exclusivity in Europe. :theflyonthewall.com |
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February 13, 2012
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| 08:15 EDT |  | BMRN |
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January 31, 2012
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| 11:21 EDT |  | BMRN |
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