Alexion RI Facility Gets EU Boost

Alexion Pharmaceuticals’s RI facility is near approval as a second source of supply for Soliris.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Alexion Pharmaceuticals’s Rhode Island manufacturing facility (ARIMF) in Smithfield, RI is near approval as a second source of supply for Soliris. The company reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a “positive opinion” recommending final approval of the facility by the European Commission, which is expected in early 2010. Separately, Alexion will meet with the FDA to provide additional available information and to di...

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