Revelations And Resolutions, In Brief
Executive Summary
News about Inhibitex, Gilenya, Genzyme manufacturing, Forest's linaclotide, and Paula Deen
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EU And U.S. Regulators Toughen CV Monitoring Requirements For Novartis's Gilenya
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.
NME Candidates For 2012 Have Modest Ambitions; Standard Reviews And Small Molecules Dominate
With the same range of novel product submissions as in 2011, the year ahead could reach an equally healthy tally of new molecular and novel biological entity approvals. But a look at upcoming applications suggests that the makeup of those classes could be very different.
Genzyme’s Framingham Plant Clears FDA; Restoring Full Supply Could Take All Year
The subsidiary of Sanofi long has pegged opening of additional plant as critical to restoring full production of Fabrazyme, which has been rationed to Fabry disease patients since a manufacturing interruption in 2009.