Regulatory & Legal
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08/27/2008
- Medicare 'Doughnut Hole' impact studied
A new analysis from the Kaiser Family Foundation quantifies why approximately 3.4 million Medicare part D enrollees, including many with serious medical conditions, reached the coverage rap in 2007, leading some to stop treatment. (Read more here)Source: Kasier Family Foundation
08/11/2008
- Affymax to continue Phase 3 Hematide program after favorable results
PALO ALTO, Calif.--Affymax, Inc. will continue phase 3 studies of its anemia drug Hematide after the independent Data Monitoring Committee (DMC) found that safety data from two trials support the continuation of the studies.In the phase 3 programs, Hematide is being evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis."These are very important reviews ...
08/06/2008
- Ortho Biotech recalls cracked vials of Procrit
BRIDGEWATER, N.J.--Ortho Biotech said it is voluntarily recalling one lot of its anemia drug Procrit after discovering cracks in the necks of a small number of vials during an inspection. The recalled lot number is P114942A, which is the only lot of Procrit affected by the recall. Ortho Biotech said approximately 44,292 vials of the recalled lot were distributed between ...
07/31/2008
- The Next Challenger to the EPO Monopoly
Editor's Note: The online version of this interview includes corrections from the print version due to transcription innacuracies.At the 45th ERA-EDTA Congress in Stockholm, Palo-Alto, Calif.-basedAffymax presented preliminary data showing its anemia drug Hematide was well tolerated and maintained hemoglobin levels in patients on and not on dialysis. In the trials, the drug was administered once-a-month to patients, but perhaps ...
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