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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
