Sometimes it’s tough for biotechs to figure out what, exactly, constitutes news. Yesterday, Cell Therapeutics Inc. issued a release stating the FDA had “concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial.” Not until the second paragraph did readers find out the most important tid-bit: that the FDA had denied their appeal regarding the cancer drug, which received a complete response letter last year. Meanwhile, Vivus Inc. issued first quarter earnings late Monday, but the piece of news everyone was most interested in – the path forward...

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, companies testing their experimental drugs in conjunction with pegylated interferon and rebavirin (PR) vs. PR alone may find enrollment and retention challenging, especially for treatment-naïve subjects. In a three-arm study that includes PR alone, patients would be signing up for a 33 percent chance of a year of flu-like symptoms with a cure rate of about 45 percent, at best....

Politics, economics, and NIH spending priorities By MARK McCARTY Medical Device Daily Washington Editor Government that makes sense. It's what we all dream of, but when it comes to spending priorities at the U.S. National Institutes of Health, we might as well wish to lose weight on the see-food diet. FYI: That's the diet on which when you see food, you eat it. What do I mean? Here's what I mean. NIH's budget for the National Cancer Institute in fiscal 2010 was a bit more than $5.1 billion (click here), but the budget for the National Heart, Lung, and Blood...