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Lumizyme
Latest Headlines
Latest Headlines
Genzyme's $150M plant upgrade starts to pay off
The company says in a release that the FDA and the EMA have given approval to a filling and finishing operation for Myozyme and Lumizyme, treatments for the enzyme deficiency known as Pompe disease.
Genzyme pumps up Pompe meds; Fabrazyme still short
Genzyme held a ceremony today in Geel, Belgium to mark the start of construction of a new €250 million ($336 million) plant and thus put it one step closer to pumping up production of its Pompe
Genzyme re-ups and beefs up business with Hospira for fill/finish ops
Genzyme will have Hospira conduct the final steps of manufacturing for a growing list of drugs under a new supply agreement. Hospira will provide fill/finish services for Cerezyme, Fabrazyme,
Genzyme's Lumizyme approved with REMS program
With the FDA approval of Lumizyme this week, Genzyme is marketing two alglucosidase alfa products to treat Pompe disease: The new drug joins Myozyme, which gained market approval in 2006. The FDA has
Genzyme: FDA will decide Lumizyme's fate in June
The FDA has told beleaguered Genzyme that a new decision on Lumizyme, the company's drug for Pompe disease, will come in June--more than six months after the agency rejected the product for the
Genzyme's Lumizyme program back on track
Genzyme's development program for Lumizyme, a therapy to treat Pompe disease, appears to be back on track. The FDA had rejected Genzyme's BLA for Lumizyme in November, saying that the biotech company
Genzyme shares sink on FDA snag
Genzyme was faced with an unexpected delay for its new therapy to treat Pompe disease after the FDA declined to give the drug its approval. And analysts quickly totted up the damage, noting that the
Genzyme expects FDA nod for new plant
Genzyme says it has polished its manufacturing act. The company is poised to boost production of its costly treatment for Pompe disease, provided FDA finally gives its blessing to a new production
