Sovaldi On The Cusp: NICE Wants More Data On Subgroups
This article was originally published in The Pink Sheet Daily
Gilead’s high-cost hepatitis C drug is surprisingly close to making it through U.K.’s cost-effectiveness watchdog.
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The contrasting views in Germany and England for the hepatitis C product underscore the difference between IQWiG’s purely scientific assessment and NICE’s focus on cost-effectiveness.
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.
The EMA has recommended suspension of some 700 drug formations linked with Indian clinical trials company GVK Biosciences, but assures national agencies that this won’t result in shortages or safety issues.