Sanofi is a healthcare company focused on patient needs and engaged in the research, development, manufacture and marketing of healthcare products. The Company also discovers, develops and distributes therapeutic solutions.
Fri, May. 30, 7:39 AM
- Sanofi (SNY) reports that the FDA agrees to review Genzyme's resubmission of its Lemtrada application for the treatment of relapsing forms of multiple sclerosis. A six-month review window has been assigned. SNY expects FDA action in Q4.
- The FDA sent Genzyme a CRL in December 2013 after reviewing its sBLA. It stated that the company failed to submit evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Apparently, the design of the completed Phase 3 active comparator studies was the problem.
- Related ticker: (GCVRZ)
Mon, Apr. 7, 7:48 AM| Mon, Apr. 7, 7:48 AM | 1 Comment
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