Bydureon FDA Deadline Set

San Diego-based Amylin Pharmaceuticals (NASDAQ: [[ticker:AMLN]]), Indianapolis-based Eli Lilly (NYSE: [[ticker:LLY]]), and Waltham, MA-based Alkermes (NASDAQ: [[ticker:ALKS]]) said today that the FDA has set a deadline of Jan. 28 to complete its review of the newly updated application for exenatide once-weekly (Bydureon). The companies are seeking FDA clearance to start marketing the new product as the first once-weekly injectable medicine for diabetes patients in the U.S. The drug was approved in the European Union in June.

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.