By Yvette Delph, MD October 3, 2001 1. INTRODUCTION In May 2001, Gilead Sciences submitted New Drug Application (NDA) 21-356 to the FDA for its VireadTM brand of tenofovir disoproxil fumarate (TDF). Gilead is seeking accelerated approval for TDF to…
Its Rapid Rise & Fall June 2001 by Mark Harrington From the Introduction If you don't have the survival data, how are you exercising your clinical judgement?... I find it hard to understand how anyone could feel that it is…
by Michael Marco 27 February 2001 On 27 February 2001, the FDA's Antiviral Drugs Advisory Committee will consider an application for approval of Hoffmann-La Roche's valganciclovir for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. BACKGROUND Cytomegalovirus (CMV)…
January 31, 2001 STRUCTURED TREATMENT INTERRUPTIONS WORKSHOP Workshop Summary The investigation of Structured Treatment Interruption (STI) has fluid borders. Interruption is considered a treatment strategy per se, an adjunct to treatment, as well as the removal of treatment. Though first…
by Derek Link with Mark Harrington July 2000 Introduction Ten years ago, when the AIDS death toll in the United States crossed 100,000, few paid heed to a grim prediction by the World Health Organization (WHO) that "by the year…
by Michael Marco and Jeffrey Schouten, M.D. July 14, 2000 Introduction By Michael Marco "Clearly the problem of HCV will require a responsible partnership of public and private organizations. . . . If we are to make progress against this…
A Statement by Gregg Gonsalves, Policy Director of the Treatment Action Group, on the Vaccines for the New Millennium Act of 2000
by Gregg Gonsalves March 2000 From the Introduction The first two decades of AIDS vaccine research have been a series of disappointments and setbacks. Indeed, while at the epidemic's outset many predicted that it would be easier to develop a…
February 2000 New York, NY by Mark Harrington At least 18 studies and speeches presented at the Seventh Retrovirus Conference included discussions related to treatment interruptions (TIs) and structured treatment interruptions (STIs) in various HIV infected populations -- including primary…