In early August, FDA announced approvals of two fixed-dose combination (FDC) antiretroviral drug products for use with other antiretroviral agents in the treatment of HIV-1 infection: GlaxoSmithKline's Epzicom® (abacavir/lamivudine) and Gilead Sciences, Inc.'s Truvada® (tenofovir disoproxil/emtricitabine).
July 2004 By Tracy Swan & Daniel Raymond INTRODUCTION TAG’s Hepatitis C and HIV/HCV Coinfection Report is a comprehensive review of basic and clinical science accompanied by recommendations for research and policy. It was written for people living with hepatitis…
By Rob Camp Edited by Jen Curry AIDS Treatment Activists Coalition (ATAC) On Tuesday, May 25, 2004, the National Institutes of Health (NIH) hosted a public meeting to seek comment from invited individuals, organizations, and other stakeholders on the use…
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…