Amylin, Alkermes Get New FDA Date

San Diego-based Amylin Pharmaceuticals (NASDAQ: [[ticker:AMLN]]) and its partners, Indianapolis-based Eli Lilly and Waltham, MA-based Alkermes (NASDAQ: [[ticker:ALKS]]), said today the FDA has set a deadline of Oct. 22 to finish reviewing the application to start selling exenatide once-weekly (Bydureon) for diabetes. The first application was filed in May 2009, and the FDA said in March that it wasn’t ready to be approved yet. Regulators aren’t requiring new clinical trials, although the companies said in March that issues remained around finalizing the prescribing information that guides physicians, along with a Risk Evaluation and Mitigation Strategy (REMS) program, and “clarification of existing manufacturing processes.”

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.