Janssen's Stelara Rejection At NICE Puts Innovation In The Spotlight
This article was originally published in The Pink Sheet Daily
Janssen's Stelara has been blocked from the NHS by NICE because, although innovative, it is not the step change that the British reimbursement watchdog wants.
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Janssen has until Jan. 17 to argue the cost-effectiveness of Stelara in the additional indication, psoriatic arthritis, while Ferring faces a restricted indication recommendation for Firmagon.
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.