Lumizyme

The therapy, developed by Genzyme Corp. and marketed under the name Lumizyme, involves intravenous infusions to replace the missing GAA enzyme in patients over 8 years of age.

PhysOrg.com - latest science and technology news stories 2010

Genzyme is now seeking approval of a large-scale production version of Myozyme, which is called Lumizyme and produced in a Belgium plant.

Genzyme Says FDA Plans Enforcement Action Thomas Gryta 2010

Genzyme is now seeking approval of a large-scale production version of Myozyme, which is called Lumizyme and produced in a Belgium plant.

Genzyme Says FDA Plans Enforcement Action Thomas Gryta 2010

Genzyme is now seeking approval of a large-scale production version of Myozyme, which is called Lumizyme and produced in a Belgium plant.

Genzyme Says FDA Plans Enforcement Action Thomas Gryta 2010

An FDA panel of outside medical experts recommended in 2008 that the FDA approve Lumizyme, which is being made at a company plant in Geel, Belgium.

FDA Approves New Version of Genzyme Drug for Rare Disease 2010

Genzyme is now seeking approval of a large-scale production version of Myozyme, which is called Lumizyme and produced in a Belgium plant.

Genzyme Says FDA Plans Enforcement Action Thomas Gryta 2010

It is now attempting to get approval of a large-scale production version called Lumizyme, produced in a Belgium plant, and expects a decision in mid-June.

Genzyme's Earnings Fall 73% as Plant Shutdown Crimps Sales Thomas Gryta 2010

The larger-scale product will be called Lumizyme, and Genzyme estimated Monday that regulatory delays will delay marketing approval for three to six months.

Generic Biologics Face Hurdles 2009

Although Genzyme sells the biologically engineered drug as Myozyme, the product made at the Boston facility would be called Lumizyme in the U.S., in a bow to the FDA's stance that the two aren't identical.

Genzyme Set Back on Plans For Drug for Pompe Disease 2009

The Food and Drug Administration is considering approval of the drug, called Lumizyme here, and says it will issue a ruling by June 17.

IndyStar.com Top Stories 2010