SANDOZ LESCOL (FLUVASTATIN) IS FIRST "ENTIRELY SYNTHETIC" HMG- CoA reductase inhibitor and "is in part structurally distinct from the fungal derivatives of this therapeutic class," labeling states. Lescol was approved as a cholesterol-lowering agent on Dec. 31 ("The Pink Sheet" Jan. 3, p. 18). It will be the fourth HMG-CoA reductase inhibitor on the market, after Merck's Mevacor (lovastatin) and Zocor (simvastatin) and Bristol-Myers Squibb's Pravachol (pravastatin).
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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.’
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.
The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.
