Biocon pulls application for EU approval of two drugs

Reuters

16 August 2017 - Biocon has withdrawn its application seeking European Union approval for two drugs after the EU drugs regulator sought re-inspection of their production facility, sending shares down more than 8%.

Biocon will re-submit the applications for breast cancer drug trastuzumab and pegfilgrastim, which cuts infection risk in patients undergoing chemotherapy, after the EMA completes the inspection, it said in a stock exchange filing on Wednesday.

"The European regulatory authorities had informed us of the need for a re-inspection of our drug product facility for these products," Biocon said, without specifying when the regulator would carry out the inspection.

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Michael Wonder

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Michael Wonder