CholesTame, a dietary supplement that "promotes normal cholesterol metabolism," according to the firm, debuted at the Natural Products Expo East in Baltimore, Md., and is now shipping to health food stores, clinicians and medical professionals. Los Angeles-based Jarrow advertised the product in the September issue of Whole Foods magazine. CholesTame contains red yeast rice extract, CoQ10 and alpha lipoic acid; 120 Quick-Solv tablets are priced at $20
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.