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MHT's Marc Songini: Researchers focus on macular degeneration
In their own words: Tod Woolf, CEO, RXi Pharmaceuticals Corp.
The FDA has informed Genzyme Corp. that the regulatory agency is not satisfied by the Cambridge-based company’s actions to fix manufacturing and maintenance problems at the Allston biologics manufacturing plant. The concerns were the subject of a February warning letter from the FDA.
Genzyme’s (Nasdaq: GENZ) stock slid 6.25 percent following the news, to $52.76 down from $56.25 for the previous close.
The U.S. Food and Drug Administration inspected the plant in May to make sure all problems were remedied -- yesterday’s letter from the FDA indicated that all promised actions had not been either fully or adequately implemented at the time.
The FDA now plans to reinspect the plant. During the re-inspection, the FDA will also review Genzyme’s decontamination efforts following the June 16 shutdown of the plant due to the discovery of the virus in one of the bioreactors. Genzyme officials have said that the virus that caused the shutdown was unrelated to the maintenance issues detailed in the FDA’s warning letter.
Genzyme officials say the sanitization of the facility is complete and the plant is now up and running. The facility produces the drug Fabrazyme, to treat Fabry disease, and Cerezyme, to treat Gaucher’s disease.
Genzyme officials say they will work with the FDA to schedule the re-inspection as soon as possible.
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