Monthly Archives: January 2009
JP Morgan Healthcare Conference:
It’s All About "Money…Rather the Economy!"
JP Morgan’s Healthcare Conference has always been about financing, but money has never been the main focus like it is at this year’s annual gathering in San Francisco. The hallmark of this investment meeting has been innovation, with companies passionately pitching their new product or technology and management team’s capability to execute on a [...]
Posted in Events Tagged Art Levinson, conference, DNA, Erich Hunziker, Gene, Genentech, healthcare, JP Morgan, Merck, NME, Richard Clark, Roche, Ted Kennedy 1 Comment
FDA Declares: Keep Taking Your Vytorin
It’s official. Vytorin (ezetimibe/simvastatin) still does what it’s supposed to do—significantly decrease LDL cholesterol.
FDA, yesterday, released its assessment of the now-notorious ENHANCE trial—which tested whether Vytorin was better than simvastatin alone in reducing arterial plaque in a group of patients with severe genetic high cholesterol. It wasn’t, and publication of the study set off a [...]
Posted in Regulatory Tagged ENHANCE, FDA, IMPROVE-IT, Merck, Schering Plough, simvastatin, Vytorin 1 Comment
Asking the Right Questions on FDA Reform
When it comes to reforming the (FDA),if you don’t ask the right questions, you won’t get the right answers. Look at the recent media coverage of the agency’s 2008 drug approval numbers.
Last year, the FDA approved more “first-of-their-kind” drugs (21) and instituted fewer “black box” warnings (46) than it did in 2007 (18 and 62, [...]

Pharm Exec Podcast Series:
Bill Trombetta Industry Audit (Part 1)