Making Sense of Clinical Trials: A Guide for BioHorizon Clients
January 21, 2010 by admin · Leave a Comment
BioHorizon’s five step guide to interpreting clinical trial results helps patients, physicians, executives, and investors make informed decisions about new medical technologies.
MannKind’s AFREZZA vs. Pfizer’s Exubera: Will Inhaled Insulin Be Different This Time?
January 21, 2010 by tim · Leave a Comment
With an FDA decision pending on Mannkind Corporation’s AFREZZA (TM) (insulin human (rDNA origin) Inhalation Powder – formerly named AFRESA ) and the recent failure of the first inhaled insulin to receive FDA approval, we thought it would be helpful to provide an analytical approach to this emerging health technology. For those who are unfamiliar [...]
ADVENTRX Pharmaceuticals, Inc. and the 505(b)(2) New Drug Application (NDA) for ANX-530
January 17, 2010 by tim · Leave a Comment
There has certainly been a lot of attention paid to ADVENTRX Pharmaceuticals over the past few days so it comes as no surprise that we have had a lot of questions concerning this company’s use of a 505(b)(2) New Drug Application (NDA) for ANX-530. This NDA is different from a full NDA (the usual for [...]