Italy's Move To Fund Off-label Avastin Use In AMD May Be Illegal, Pharma Groups Say
This article was originally published in The Pink Sheet Daily
EFPIA, Novartis and Roche believe that a decision by the Italian regulatory authority, AIFA to allow reimbursement for the off-label use of Avastin in place of Lucentis may be against EU law.
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With EMA deliberating about Avastin, Novartis and Roche have confirmed that they will appeal the €180.5 million fine imposed on them by Italy’s competition authority for anti-competitive behavior.
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.