Success Of Bristol’s Daklinza In Europe May Be Tied To Fate Of Sovaldi
This article was originally published in The Pink Sheet Daily
The close relationship between Bristol-Myers Squibb’s Daklinza and Gilead’s Sovaldi for HCV means the triumph or failure of the latter drug in HTA processes might determine the future of both in Europe.
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Daklinza has been part of the standard of care in genotype 3 HCV, but the launch of Gilead's Epclusa and an EU ramp-up of Merck's Zepatier are expected to erode that over time.
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.