Aegerion’s Juxtapid Needs Long-term Post-Market Cohort Study After FDA Nod
This article was originally published in The Pink Sheet Daily
Executive Summary
Sponsor will institute a registry to monitor patients taking the LDL cholesterol-lowering drug for homozygous familial hypercholesterolemia for 10 years, as part of an approval that is a likely template for Genzyme’s Kynamro.
You may also be interested in...
Kyle Bass Claims Pink Sheet Article As Prior Art In Juxtapid Patent Challenge
University of Pennsylvania argues neither 2004 article nor slide presentation it describes constitutes prior art that would invalidate method of use claims.
Aegerion’s Lojuxta Submission To Germany's IQWIG Disappoints
IQWIG’s review is now open for consultation, with Germany's top HTA body the G-BA expected to make a final decision about the benefits of the ultra-orphan in December.
One In A Million: Aegerion Looks To Raise The Price Of Myalept
Company sees “opportunity for a one-time price increase” when it takes over the lipodystrophy drug’s launch from AstraZeneca. At a current cost of about $325,000 per year, metreleptin already is on the ultra-high spectrum on par with other rare disease drugs.