FDA Will Create “Limited” Rx Import System, Ex-CMS Head Predicts
• By The Pink Sheet
The Bush Administration will initiate a "limited" pharmaceutical importation program during 2004, former Centers for Medicare & Medicaid Services Administrator Tom Scully predicted during the Medco drug trend symposium May 18 in Lake Buena Vista, Fla
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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 has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.