Pfizer launches the antifungal Eraxis (fluconazole) the week of May 15. The wholesale acquisition cost is $90 per 50 mg vial plus diluent, although the hospital price will vary depending on location. FDA approved Eraxis Feb. 17 to treat a variety of types of Candida infections (1"The Pink Sheet" Feb. 22, 2006, p. 3). The average wholesale price for the firm's other Candida infection treatment Vfend (voriconazole) is approximately $110 for 200 mg...
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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.