San Diego-based Optimer Pharmaceuticals said today it is preparing to apply for approval to sell fidaxomicin (OPT-80) in the European Union on the basis of one successful Phase III trial. The company reported positive results of the new antibiotic in November from the first of two pivotal studies for patients suffering from “C. Diff” bacterial infections. The company says it still intends to complete the second study before it will seek approval for marketing from the U.S. Food and Drug Administration.
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.
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