With Avastin Approval For Breast Cancer, Will More Patients Hit Price Cap?
• By Brian Marson
FDA approval of Genentech's Avastin for first-line treatment of metastatic breast cancer may trigger the first significant trial of the biotech's Avastin patient assistance program, which caps annual drug expenditures at $55,000 for approved indications but has not seen much utilization by colorectal or non-small cell lung cancer patients
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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