Barr acquires King's hormone replacement therapy Prefest for approximately $15 mil. The deal is part of King's strategy to divest "many, if not all" of its women's health products, King said Nov. 22. Barr and King are involved in pending litigation over patents related to Prefest (estradiol/norgestimate); the case will be voluntarily dismissed after the product acquisition. King has plans to merge with Mylan (1"The Pink Sheet" Nov. 1, 2004, p. 21)...
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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.