Cell Therapeutics (NASDAQ: [[ticker:CTIC]]), the Seattle-based company developing pixantrone for non-Hodgkin’s lymphoma, said today that the FDA has certified that a contract manufacturer is ready to make the treatment. The factory, run by NerPharMa in Italy, was inspected and found to be in compliance and acceptable for continued manufacturing, Cell Therapeutics said. The treatment is expected to be examined by an FDA advisory panel on March 22, and the agency has an April 23 deadline to complete its review of whether to clear pixantrone for sale as a treatment for non-Hodgkin’s lymphoma.
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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