Geneva Augmentin generic reserve: Geneva's generic amoxicillin/clavulanate earnings are being placed in a reserve in the event the company loses GlaxoSmithKline's appeal of the Augmentin patent lawsuit, Novartis CEO Daniel Vasella said July 22. "We will book sales, but we will not book the earnings out of this product but put them in a reserve," the exec said. "The additional exposure should we - against all odds - lose the appeal next year, would be an amount which we can digest, I would say, rather easily." GSK is appealing a May 22 ruling in Geneva's favor; a decision could come as early as January (1"The Pink Sheet" May 27, p. 20). Geneva launched amoxicillin generics in June...
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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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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.