Category Archives: Phase III

Patient Experience Still Undervalued in Regulating Drugs

As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The…

Share

He Said What?!?! Best Biotech Quotes of 2011

As BioWorld Insight readers know, our “Word on the Street” column provides a sample of the most entertaining and thought-provoking quotes our staff stumbles upon each week. Some are gathered during interviews, some gleaned from analyst reports, and some overheard…

Share

The Good, the Bad and . . . the Huh? A 2011 Biotech Recap

The past year brought the biotech sector a mixed bag of news. Some of it was positive – for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech…

Share

World’s Oldest Clinical Trial . . . and Health Economics Not Far Behind

How old is our clinical trial system? The first randomized clinical trial was conducted in 1946. British epidemiologist Sir Austin Bradford Hill used randomization to test a pertussis vaccine and a tuberculosis treatment. But according to an article in the…

Share

LJPC, GNTA Not Dead Yet

It looked Monday as if two of biotech’s long-suffering names might finally be biting the dust. Genta Inc. threw in the towel on beleaguered antisense drug Genasense (oblimersen sodium), after a final analysis of a Phase III melanoma trial –…

Share

Race To Nowhere

Racial profiling – long in the realm of bad law enforcement – was criticized as bad medicine, too, in a recent paper by scientists from the Mount Sinai School of Medicine. The reason? As the authors put it, “cosmopolitan cities…

Share

HCV Trials Face Daunting Challenge

Recruiting subjects for ongoing Phase III hepatitis C virus (HCV) trials just got a lot harder. Even if the FDA doesn’t step in and force a change in the standard-of-care control arms after last week’s Antiviral Drugs Advisory Committee meetings,…

Share