pharmaphorum11y
FDA rejects Genzyme’s biological drug for MS
The US drug regulator the FDA has made a final decision on the biological drug developed by Genzyme (Sanofi) for use in multiple sclerosis, alemtuzumab (Lemtrada), failing to approve the ...
Nature17d
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 alfa, rhGAA) in its 2,000–liter-scale facility under ...
FiercePharma16d
FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...