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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
