Debra B Birnkrant, MD Center for Drug Evaluation and Research Office of New Drugs Division of Anti-Viral Products (HFD-530) CRPII/Rm. N414 Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 Fax: 301.827.2523 Dear Dr Birnkrant, I am…
Regardless of HIV status, transplant candidates face a daunting shortage of livers "The organ shortage is a crucial problem. We need to keep working to expand the donor pool. I see people dying because they can't get organs." by Tracy…
February 2004 By Rob Camp Not so fast! Where's my pipeline? Pipelines are almost as delicate and fragile as the ecosystems they go trampling through. Oft times the way to get from the beginning to the end is not a…
And speaking of boosting… By Rob Camp and Heidi Nass December 2003 Executive Summary FDA granted accelerated approval to Agenerase® brand amprenavir (NDA 21-007 and NDA 21-039) in April 1999. 908 allows us an opportunity to get an easier-to-use drug…
By Rob Camp The pipeline is bursting, with at least the following compounds twinkling in the eyes of scientists around the globe. It is by no means a full list, but those substances in red were presented at the recent…
June 2003 By Rob Camp To lipid it or not to lipid it From the Introduction Atazanavir (ATV) is an azapeptide protease inhibitor under development by Bristol- Myers Squibb, licensed from Novartis. Overall, the drug looks virologically similar to nelfinavir…
TAG Basic Science Project 2003 Retrovirus Conference Report By Richard Jeffreys May 2003 Nabbing the V3 Loop One major theme that emerged at this year's Retrovirus conference was a renaissance of interest in neutralizing antibodies. Antibodies are small Y-shaped molecules…
2003 by Rob Camp INTRODUCTION FTC is a once-daily (QD) thiacytidine nucleoside analogue developed by Triangle Pharmaceuticals, North Carolina. Triangle is now owned by Gilead Sciences. The compound was licensed from Emory University in 1996. It comes in 200 mg…
By Matt Sharp and Rob Camp for the Treatment Action Group (TAG) and Other Endorsing Community Organizations and Individuals (List Below) March 7, 2003 Introduction Research and advocacy have brought forth 16 approved antiviral medications targeting two different stages in…