Mylan, Biocon get CRL for insulin glargine follow-on

Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said they recently received a complete response letter from FDA for their follow-on of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY).

The partners said they expected the decision and have already started the required activities the companies agreed on with FDA, which include providing the agency with additional clinical data to allow the partners to change the compound's manufacturing site to Malaysia from Bangalore...