20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...
Sanofi has settled a long-running dispute with shareholders in the biotech Genzyme, who claimed the big pharma deliberately held back development of a multiple sclerosis drug to avoid payments ...
Genzyme Corp. (Sanofi Genzyme) has disclosed sodium-dependent neutral amino acid transporter B(0)AT1 (SLC6A19) inhibitors reported to be useful for the treatment of phenylketonuria, among others.
Genzyme has fallen foul of the UK pharma industry code, for making misleading and disparaging claims about a competitor product. AstraZeneca has also been named in advertisements along with the ...
Genzyme of Cambridge, Massachusetts, faces millions in lost revenue from its top-selling specialty drugs Cerezyme and Fabrazyme as result of a viral contamination at its Allston, Massachusetts plant.
The company remains convinced of the product's merits and—bolstered by the backing of a $1.38 billion deal from Genzyme a year ago—continues to pursue cardiac and other autoimmune indications.
Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.
Chesbrough, Henry W., and Clarissa Ceruti. "Genzyme: Engineering the Market for Orphan Drugs." Harvard Business School Case 602-147, March 2002. (Revised May 2002.) ...
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