NICE Yervoy, Invokana Rulings Show Need for Regulator/HTA Dialogue
This article was originally published in The Pink Sheet Daily
NICE downgrades BMS’ Yervoy, while Janssen omits filing for all combinations for Invokana, underscoring the need for EU harmonization through HTA/regulator dialogue.
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J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.
NICE has recommended Roche’s Zelboraf and BMS’ Yervoy, as expected based partly on undeniable life extension capabilities, but also on secret price discounts offered by both manufacturers.
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.