Pfizer/Eyetech's Macugen reimbursed at $1,054.70 per injection under Medicare Part B average sales price plus 6% model. Macugen, which FDA approved Dec. 17 for the treatment of neovascular (wet) age-related macular degeneration, carries a list price of $995 per injection (1"The Pink Sheet" Jan. 3, 2005, p. 7). Labeling recommends Macugen be administered every six weeks, bringing the treatment's annual cost based on list price to $7,960 per eye, and CMS' annual reimbursement per eye to $8,437.60 (2"The Pink Sheet" Jan. 10, 2005, p. 20)...
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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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FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
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