United Therapeutics' pulmonary arterial hypertension therapy Remodulin (treprostinil) clears FDA May 21 via accelerated approval. The company's Phase IV confirmatory study will assess safety and efficacy of the drug in approximately 100 PAH patients who were stable on GlaxoSmithKline's Flolan (epoprostenol). Subjects will be withdrawn from Flolan and randomized to Remodulin or placebo for eight weeks. Remodulin is indicated for use in PAH "patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise." The drug is given as a continuous subcutaneous infusion via a portable infusion pump, while Flolan, indicated for PAH patients with NYHA Class III and IV symptoms, requires intravenous administration through a central venous cathete
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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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