The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
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 ...
Sanofi (NYSE: SNY) acquired the Framingham facility when it bought Massachusetts-based Genzyme in a deal worth over $20 billion in 2011. Genzyme became a subsidiary of Sanofi and kept the Genzyme ...
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 FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...
The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...
Sanofi has finally 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 ...
Although Genzyme has no equity stake in Osiris, which will keep all US and Canadian rights to its MSC products and indications, the Cambridge, Massachusetts–based company does get commercial ...