Aegerion’s Lojuxta Submission To Germany's IQWIG Disappoints
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
Sanofi’s Praluent Closes Gap On Repatha In Europe, As GSK Gets Green Light For World’s First Malaria Vaccine
Europe’s CHMP grants positive opinions for Sanofi’s Praluent and GSK’s not-for-profit malaria vaccine Mosquirix at July meeting; other products recommended include Shire’s Intuniv, Merck’s Zerbaxa, Basilea’s Cresemba and Keryx’s Fexeric.
Europe Backs Celgene’s Pomalidomide And Aegerion’s Lomitapide
Positive opinions from Europe's top drug assessment panel in May have included a long-acting "biobetter" lipegfilgrastim from Teva, a once-weekly HGH injection from Biopartners GmbH, and a smallpox vaccine developed by Bavarian Nordic with funding from the U.S. BioShield program.
Aegerion’s Juxtapid Needs Long-term Post-Market Cohort Study After FDA Nod
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.