Launch preparations underway for "potential availability of desloratadine for the spring 2001 allergy season." Desloratadine is an active metabolite of Schering-Plough's Claritin (loratadine). An NDA was filed for the treatment of seasonal allergic rhinitis Oct. 21, 1999 and for chronic urticaria Aug. 31, 2000. The company has not disclosed the product's regulatory review status and "has not made a prediction regarding the timing of U.S. regulatory approval for desloratadine" (1"The Pink Sheet" Oct. 16, p. 16)
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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 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.
