The European Medicines Agency said Monday it was notified by Abbott Laboratories Limited of its decision to withdraw its application for a centralized marketing authorization for the medicine Ozespa, briakinumab, 100 mg solution for injection. Get the full story »
Inside these posts: European Medicines Agency
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EU regulator warns on Baxter dialysis solutions
The European Medicines Agency said on Friday that current stocks of Baxter International’s peritoneal dialysis solutions should be replaced because of the possibility of contamination. The regulator was informed by Baxter of the potential presence of endotoxins in Dianeal, Extraneal and Nutrineal — three sterile solutions used in patients who have to undergo dialysis because of kidney failure. Get the full story »
Avandia faces ban in Europe, severe limits in U.S.
European regulators said Thursday GlaxoSmithKline’s diabetes drug Avandia should be taken off the market but U.S. officials allowed it to stay, with major restrictions due to concerns about heart risks.
The differing rulings were an attempt to end a row over drug safety that has dogged the reputation of the medicine and its maker in recent years. Get the full story »
