FDA's Oncological Drug Advisory Committee Recommends DOX-SL for Accelerated Approval--But Not Without A Fight 'Nothing but ugly' Michael Marco reports back from FDA-land, where there is always a story to tell, and usually more than one way to tell it…
FDA Just Says "No" To Salk Immunogen. The illustrious Dr. Jonas Salk and officials of his Immune Response Corp. appeared before an FDA advisory committee on 26 January seeking approval for large-scale Phase III efficacy trials of its envelope depleted…
Merck's Scientists Cave In To The Vogue of Surrogate Marker Endpoint Trials, Accelerated Approval And Quick Cash Dr. Emini's Gamble David Barr, David Gilden (GMHC), Mark Harrington, Michael Ravitch, Theo Smart (TAG), Ben Cheng, Marty Delaney, Joel Thomas (Project Inform),…
Inauspicious Debut for HIV Specific CTLs; New Concerns about IL-12; Neutralizing Approaches for "Bad" Cytokines; Parke-Davis Targets Cellular Factors Souped-Up Abs from LTNPs The Clinical Immunology Society's 2nd HIV Immune-based Therapies Workshop was held in Baltimore on January 27-29. Attendance…
Fascinating Work on HIV and T-Cell Kinetics Challenges Longtime Dismissal of Ravaged Immune System's Regenerative Potential The CTL As Both Villain and Victor Picture this. Dr. David Ho approaches a half-filled tub of water, with water still more or less…
New ACTG Structure Squeezes Eleven Committees Into Three--But Will Anything Really Be Any Different? Remaking the 'Iron Lady' Once again the AIDS Clinical Trials Group (ACTG) has been restructured. This has occurred three times in as many years. Are the…
Like the Wings of Icarus, Treatment Hype Sweeps Its prey Upward to the Heavens, Then Plucks Them Down Into icey Waters Dividends from Desperation While all the Western world beats its chest, proudly promoting the renewed, if disputatious, promise of…
With Good Intenntions, Over-Zealous Researchers May Be Setting the Stage For Yet Another Colossal Failure When Viral Load Is Crowned King Towards the beginning of a recent conference on Surrogate Markers for HIV Infection held in Arlington, VA, Donna J…
What the New Republican Congress Will Mean for AIDS Prevention, Treatment and Research The Horror of 'Block Grants' On November 8, 1994 less than 25% of the American electorate voted for a new Congress dedicated to radically reducing the size…
Planning for Efficacy Rates of 30-50%, Roche Protease Trials Shoot for Distant Stars Deja Vu All Over Again Peter Staley spoke before a meeting of the National Task Force on AIDS Drug Development (of which he is a member) on…