Pharma’s Cutting Edge

Pharma’s Cutting Edge

Pharmaceutical and biotech science and business

 
 
 
 

Archive for Clinical Research

FDA supports use of ezetimibe (Zetia/Vytorin) after review of ENHANCE findings

As regular readers will remember, I am a user of ezetimibe (Zetia, Schering-Plough & Merck) for LDL-C reduction beyond that provided from the statin I also take.  Before and after ENHANCE preliminary results were released and again after they were published, I wrote editorials outlining my opinion that appropriately selected users of ezitimibe should in most cases [...]

Round-up of (unethical?) osteoporosis studies from ASBMR 2008

 
ASBMR was eventful this year, with PMP osteoporosis trial news from several companies, most notably fracture data from Amgen’s denosumab and comparative BMD data from Merck’s odanacatib.
Of course, it’s easy enough for you to learn about these presentations from other news sources, so I won’t spend much time on them.  Here’s the gist:  Denosumab, the [...]

NICE against sequential use of TNF blockers for Rheumatoid Arthritis: A payer’s demand for good evidence

BBC on NICE Final Appraisal Determination for TNF-alpha inhibitors in RA
My marketing colleagues’ have generally argued that there are limited funds for studies, and such funds ought not be spent studying the competition, unless the plan is to go head to head and whoop some ass.  My argument in return has been that clinical trials [...]

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ENHANCE results now available (follow-up)

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 [...]

MyVax misses the mark: Genitope seems not to notice

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 [...]

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