Europe Clears Roche Cancer Drug After Contamination Report

Law360, New York (May 25, 2012, 1:25 PM EDT) -- A European Medicines Agency committee said Friday that problems surrounding bacterial contamination of Roche Holding AG cancer drug MabThera have been resolved and that the tainted product never posed a direct threat to human health.

European regulators launched their inquiry after Roche last year revealed it had discovered L. licerasiae bacteria in bioreactors at a Vacaville, Calif., manufacturing plant.

According to the EMA, the contaminant, which can cause severe infections, was detected during a routine microscopic examination during early stages of production. The bacteria were not...
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