With legislation possibly creating a regulatory pathway for follow-on biologics (biosimilars, generic biologics, biogenerics, et al.) in the US as early as 2009 (but more probably later), I figured it’s time to break out the for-no-good-reason top-10 list of major players in this coming market and their first likely drugs approved. I guarantee that at [...]
Above: NMR solution structure of exenatide from Ganfyd.org
taspoglutide advancement announcement
Lead 6 results press release
52-week data from Duration-1 trial
A bit more excitement than usual surrounded this year’s recently completed ADA annual meeting, with a flurry of news surrounding the GLP-1 mimetics and their brethren, the DPP-IV inhibitors.
In my mind, the most interesting bit of news concerned progress [...]
This is a f/u to the piece I wrote in January describing the preliminary (but widely publicized) results from the ENHANCE study of simvastatin and ezetimibe (Zetia) (combination tablet sold as Vytorin by Schering-Plough and Merck) in patients with familial hypercholesterolemia. The study looked at the effects of the combination versus simvastatin alone on carotid intima-media thickness. [...]
Results from ENHANCE are now available. I don’t think anyone is terribly surprised, given the delay in reporting the results, that addition of ezitimibe to simvasatin (i.e. Vytorin) did not have a sigificant impact on carotid intimal media thickness compared with simvastatin (Zocor) alone in subjects with heterozygous familial hypercholesterolemia (a disorder of LDL receptors that affects [...]
Genitope’s Webcast
A week ago Genitope reported the results of a pivotal Phase 3 trial for its only clinical candidate, the idiotype-specific, personalized active immunotherapy for Non-Hodgkin’s Lymphoma, known as MyVax. I’ve been interested in this budding therapy since around the time the company went public in early 2004, which roughly coincided with the start of [...]
