Alexion (ALXN), BioMarin (BMRN) Could Offer Treatment for Sick Portfolio - Cramer
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Alexion Pharma (ALXN) Receives cGMP Warning Letter from FDA for R.I. Facility
March 28, 2013 6:46 AM EDTOn March 27, 2013, Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding compliance with current Good Manufacturing Practices (cGMP) at our Rhode Island manufacturing facility. The Warning Letter follows an FDA inspection which concluded on August 6, 2012. At the conclusion of that inspection, the FDA issued a Form 483 Inspectional Observations, to which Alexion responded in August 2012 and provided additional information to the FDA in September and December 2012. The observations concern commercial and clinical manufacture of Soliris at this facility. Based on current information, we... More
