A Phase II trial miss is usually nothing to shout about, but Actelion Pharmaceuticals Ltd. put an optimistic gloss on macitentan's failure to demonstrate efficacy in idiopathic pulmonary fibrosis (IPF), emphasizing its favorable safety profile, which could augur well for an ongoing Phase III trial in pulmonary arterial hypertension (PAH).
LONDON – Amsterdam Molecular Therapeutics (AMT) NV is now poised to begin the Phase III extension study of Glybera, its gene therapy treatment for lipoprotein lipase deficiency, and is paring back expenditure as it awaits a response from the European Medicines Agency (EMA) to its request for a re-examination of the Glybera file. (BioWorld International)
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