EU And U.S. Regulators Toughen CV Monitoring Requirements For Novartis's Gilenya
This article was originally published in The Pink Sheet Daily
A review of a potential association between Novartis's oral multiple sclerosis therapy Gilenya and sudden death was inconclusive, say EU regulators, but monitoring requirements are still strengthened as a precaution.
You may also be interested in...
EMA Passes GSK’s Mekinist, Extends Indications For Gilenya And Pradaxa
The EMA recommended authorizing a single drug this month, GSK’s Mekinist, while giving the nod to seven others, including Novartis’ Gilenya and Boehringer Ingelheim’s Pradaxa.
Novartis To Increase Marketing Support As New Products Drive Growth In The Second Quarter
Novartis highlights its under-appreciated new product portfolio as total sales increase by 1% in the second quarter, buffeted by adverse currency movements, generic competition to Diovan and enoxaparin, and manufacturing issues.
Sanofi Sets Sights On Multiple Sclerosis Leadership
With the release of “unprecedented” data on its Phase III MS candidate alemtuzumab and its once-daily oral therapy teriflunomide already under regulatory review, Sanofi looks for a leadership role in the increasingly fragmented market it expects will approach $20 billion by 2016.