Biogen Idec’s Tecfidera Facing Tough Pricing Talks In Germany
This article was originally published in The Pink Sheet Daily
Germany’s IQWiG says a lack of appropriate data from Biogen Idec means any added benefit from its oral MS drug over existing therapies cannot be proven.
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Under forthcoming changes to the law, companies could gain confidential pricing in Germany, which could make it easier to defend a higher price in other countries. But sponsor of some orphan products may face a rockier path to market.
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.