Lilly ICOS submits a complete response to FDA's April 2002 "approvable" letter for Cialis (tadalafil), the firm announces July 1. The second quarter 2003 submission extends the action date to the fourth quarter of 2003 and contains "clinical pharmacology and other data" requested by FDA. The agency also requested pharmacology studies for Bayer's competing erectile dysfunction therapy, Levitra (vardenafil), which became approvable in July 2002 (1Pharmaceutical Approvals Monthly Aug. 1, 2002, In Brief)...
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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.