Bydureon regulatory update

AstraZeneca disclosed in its 2Q14 financial results that in July EMA’s CHMP recommended approval of the company’s Bydureon Pen for self-injection of once-weekly Bydureon exenatide to treat Type II diabetes. AZ said the pen contains the same formulation and dose as the single-dose tray that is approved in the EU. FDA approved Bydureon Pen in March. In February, AZ acquired full ownership of the diabetes business it shared with Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.). The deal gave AZ full rights to the portfolio of compounds that BMS gained in its 2012 acquisition of Amylin Pharmaceuticals Inc., including Bydureon (see BioCentury, Dec. 23, 2013; Feb. 10, 2014; & March 10, 2014). ...