EMA Passes GSK’s Mekinist, Extends Indications For Gilenya And Pradaxa
This article was originally published in The Pink Sheet Daily
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.
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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.
IQWiG’s failure to find any added benefit from Novartis’ oral MS drug Gilenya in two out of three of its target patient groups, on the grounds of insufficient evidence, puts pressure on the drug following a similarly negative recommendation by U.K. cost-watchdog NICE at the end of 2011.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.