An FDA panel of health experts voted to support approval for mass production of Genzyme's Myozyme for the treatment of Pompe disease, a rare muscle disorder that can lead to fatal respiratory ...

SAN FRANCISCO (MarketWatch) -- Genzyme Corp. said Thursday that it has initiated a clinical trial evaluating the safety and efficacy of Myozyme in patients with late-onset Pompe disease, a ...

Genzyme Corp <GENZ.O> said on Monday U.S. regulators asked the company to submit a new drug application before it can market a larger-scale version of Pompe disease treatment Myozyme, which will ...

Sanofi is developing a new experimental enzyme-replacement therapy that could succeed Myozyme as a treatment for Pompe disease, part of the drugmaker’s plan to bolster the product pipeline of ...

Synpac, a subsidiary of a Taiwanese company, agreed to a 15-year royalty sharing deal for Myozyme that will net up to $821 million. Genzyme licensed the therapeutic in 2000 for Pompe's disease. ...

Genzyme currently produces Myozyme and Lumizyme at an adjacent plant in Geel, where it is increasing production capacity to 12,000 liters with the addition of a third bioreactor scheduled for ...

BOSTON, Feb 26 (Reuters) - Genzyme Corp said on Thursday it has won European approval to make its drug Myozyme at a 4,000-liter manufacturing facility, expanding supply for patients with the rare ...

Firm is also expanding capacity at its current plant. Genzyme will build a €250 million manufacturing plant in Geel, Belgium, for its Pompe disease therapies, Myozyme® and Lumizyme®.

Myozyme was first approved in 2006, and is the only approved treatment for Pompe disease. In Europe, Myozyme is indicated for infants, children and adults and the prescribing information has ...

Nature Biotechnology - FDA balks at Myozyme scale-up. Genzyme ran into a snag in April when the US Food and Drug Administration (FDA) rejected its application to produce Myozyme (alglucosidase ...

Genzyme Corp.'s new version of Myozyme, used to treat people with a rare genetic condition called Pompe disease, wasn't shown convincingly to be effective and may trigger severe allergic reactions ...

IT'S the money or his life. Tradesman Brad Gibson needs to find $500,000 a year to pay for drugs that will allow him to see his three children grow up.