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FDA Seeks More Data on Actelion's Zavesca [BioWorld Today]
(10 Mar 2010 00:01:00 EST)
Actelion Ltd. said that the FDA has asked for more preclinical and clinical information for Zavesca, a potential treatment for a rare neurodegenerative genetic disorder that currently is under review by the agency. The company, based in Allschwil/Basel, Switzerland, said that it will work with the FDA to sort out how to address the issues raised by the agency in a complete response letter.
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Actelion Shares Fall on Tracleer Miss; IPF Bid for Drug Dropped [BioWorld International]
(03 Mar 2010 00:01:00 EST)
Shares in Actelion Ltd. hit a three-year low Monday on news that its top-selling drug Tracleer failed to demonstrate efficacy in idiopathic pulmonary fibrosis. Initial results from a 616-patient Phase III trial, called BUILD-3, indicated that the drug failed to attain the primary endpoint of a reduction in morbidity or mortality.
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Actelion Shares Fall on Tracleer Miss; IPF Bid for Drug Dropped [BioWorld Today]
(02 Mar 2010 00:01:00 EST)
Shares in Actelion Ltd. hit a three-year low Monday on news that its top-selling drug Tracleer failed to demonstrate efficacy in idiopathic pulmonary fibrosis. Initial results from a 616-patient Phase III trial, called BUILD-3, indicated that the drug failed to attain the primary endpoint of a reduction in morbidity or mortality.
