The FDA has told Cambridge, MA-based Genzyme (NASDAQ:[[ticker:GENZ]]) that the agency plans to make a decision on its application for approval of Pompe drug alglucosidase alfa (Lumizyme) made in 4,000-liter batches by June 17, according to the company. The agency decided not to approve the treatment in November, citing lingering issues at Genzyme’s Allston Landing plant in Boston, where the drug is no longer manufactured. Genzyme plans to manufacture the treatment—which is marketed outside the U.S. as Myozyme—at its facility in Geel, Belgium.
Author: Ryan McBride
Ryan is an award-winning business journalist who contributes to our life sciences and technology coverage. He was previously a staff writer for Mass High Tech, a Boston business and technology newspaper, where he and his colleagues won a national business journalism award from the Society of American Business Editors and Writers in 2008. In recent years, he has made regular TV appearances on New England Cable News.
Prior to MHT, Ryan covered the life sciences, technology, and energy sectors for Providence Business News. He graduated with honors from the University of Rhode Island in 2001 with a bachelor’s degree in communications. When he’s not chasing down news, Ryan enjoys mountain biking and skiing in his home state of Vermont.
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