BioCentury's websites will be down for upgrades starting at 9 p.m. PDT on Monday, August 26. We expect the downtime to last no more than 6 hours, and we apologize for any inconvenience.

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....

Read the full 356 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Week In Review

Article Purchase

$35 USD
More Info >