Pharma’s Cutting Edge

I haven’t written much lately, I know. And now I’m just giving you a news story and some links to previous blog pieces.  Too bad you’re not able to cancel your subscription in anger. 
It won’t be terribly surprising to those of you who’ve kept an ear to the ground in the metabolism area to learn that [...]

October 23rd, 2008 | Category: EMEA, Technology | Comments (1)

Every so often, I like to pick apart a company press release for analysis.  Primarily I do this for the educational opportunity, not only for my readers but also for me.  It’s a good way to catch up to what’s happening in a hot therapeutic area if nothing else.  I’ve chosen Human Genome Sciences and GlaxoSmithKline’s Announcement   of their initiation [...]

February 18th, 2007 | Category: Clinical Research, EMEA, FDA, For Investors | Leave a comment

Will post some stories that happened while I was away from the office. This first one is from Randall Willis at DDN, who reports that the EMEA and FDA will jointly review and comment upon Voluntary Genomic Data Submissions (VGDS). This is fairly big news that received virtually no media attention, perhaps because observers have [...]

August 22nd, 2006 | Category: EMEA, FDA | Leave a comment

For this month’s PCE column, I wanted to say something about interim analyses. They’re in the news nearly every day, attesting to their importance, and yet they are not well understood by most people in the industry, the academic community or lay public. Problem is, there’s a lot to say about interim analyses, and I [...]

August 8th, 2006 | Category: Biostatistics, Clinical Research, EMEA, FDA, R&D | Comments (1)