Protalix BioTherapeutics, the Israel-based biotech company, said today it has received “fast-track” status with the FDA for its experimental drug for Gaucher’s disease. The designation allows the company (AMEX: [[ticker:PLX]]) to submit pieces of information for its new drug application as they become available, rather than waiting for everything to be finalized, and gives the company the potential for faster-than-usual product approval. The FDA has already allowed patients to get expanded access to the Protalix drug in clinical trials this month, as Genzyme’s market-leading imiglucerase (Cerezyme) suffers from a manufacturing shortfall.
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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