Cambridge, MA-based Dyax (NASDAQ: [[ticker:DYAX]]) said today that its lead drug in development, DX-88, failed to win FDA approval on schedule. The company said it needs to answer more questions about the chemistry, manufacturing, and controls section of its application, and for a risk evaluation and mitigation strategy. The company doesn’t need to do more clinical trials. The product is for treating acute attacks of hereditary angioedema, a condition that causes painful swelling of the extremities.
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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