Pricing Of Zydelig And Imbruvica Will be Scrutinized After EMA Nod
This article was originally published in The Pink Sheet Daily
Gilead's Zydelig and Janssen's Imbruvica have both been recommended for approval for leukemia treatment by the EMA, but with austerity still around in Europe member states will be scrutinizing these high-priced orphan drugs.
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With a monthly cost of $10,900/month for the ultra-rare disease mantle cell lymphoma, Pharmacyclics and Janssen are being proactive about patient aid with a 30-day offer while reimbursement is worked out, as well as other support offerings that have become part of the new reality for high-priced oncologics.
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.