An FDA expert committee has rejected a proposal to set a clear limit on the use of anemia drugs made by Amgen [1] and Johnson & Johnson [2]. One regulator remarked that there was no consensus on a target for a recommended dose. The rejection marks a victory for both companies, which has seen their revenue drop after safety issues regarding anemia drugs were raised. The FDA says it expects to finalize label changes on anemia drugs in a matter of days.
- read the report [3] from The Wall Street Journal (sub. req.)
Related Articles:
Amgen wins a round in anemia ruckus. Report [4]
Amgen discusses the future with analysts. Report [1]
New rules limit use of anemia drugs. Report [5]
J&J makes cuts at Alza and Scios. Report [2]
New study points to danger of anemia drug. Report [6]
Links:
[1] http://www.fiercebiotech.com/story/amgen-discusses-future-analysts/2007-09-11
[2] http://www.fiercebiotech.com/story/j-j-makes-big-cuts-alza-and-scios/2007-08-01
[3] http://online.wsj.com/article/SB118955435116324437.html?mod=dist_smartbrief
[4] http://www.fiercepharma.com/story/amgen-wins-round-anemia-ruckus/2007-09-12
[5] http://www.fiercebiotech.com/story/new-rules-limit-use-of-anemia-drugs/2007-07-31
[6] http://www.fiercebiotech.com/story/new-study-points-to-danger-of-anemia-drug/2006-11-16