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12:00 AM
 | 
Feb 07, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

Mircera methoxy polyethylene glycol-epoetin beta regulatory update

Roche disclosed in its 4Q10 earnings that it submitted a regulatory application to China's State Food and Drug Administration (SFDA) for Mircera methoxy polyethylene glycol-epoetin beta to treat renal anemia. The drug is marketed in Europe to treat anemia associated with chronic kidney disease (CKD) and was approved by FDA in 2007, but its launch has been delayed by litigation. In 2009, a U.S. judge ruled that Mircera infringed patents held by Amgen Inc....

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