On The Offense: Sanofi Suits Up For A Game Change
Executive Summary
Having exited its patent cliff and advanced several drugs into late-stage development, Sanofi is moving into a new commercial-centric phase. Its future looks bright, but success is not guaranteed.
You may also be interested in...
Sanofi/Regeneron’s PCSK9 Inhibitor Gets Reassuring CV Data – And A Priority Review Voucher
Alirocumab was associated with lower rate of major cardiovascular events compared to placebo in post-hoc, interim Phase III analysis – boosting chances for FDA approval in 2015. The firm is taking no chances on review period, purchasing a priority review voucher from BioMarin.
Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials
Rater-blinded design for multiple sclerosis claim netted an approval in Europe but a rejection by FDA, which was concerned about bias related to open label studies.
The Bell Tolls For Fedratinib In A Setback For Sanofi’s Oncology Portfolio
The company has halted clinical trials testing its Phase III JAK2 inhibitor fedratinib after determining that the risks of treatment outweigh the benefit after cases of the neurological condition Wernicke’s encephalopathy emerged in patients.