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June 5, 2014
06:36 EDTITMNBoehringer says nintedanib marketing authorization granted by EMA
Boehringer Ingelheim announced that the application for marketing authorization of nintedanib, a tyrosine kinase inhibitor, for the treatment of idiopathic pulmonary fibrosis has been validated and granted accelerated assessment by the European Medicines Agency. The company said, "Nintedanib, two capsules a day, is the first targeted treatment for IPF that has consistently demonstrated to slow disease progression in IPF by significantly reducing the decline in lung function by half with a manageable side effect profile." On May 27, InterMune (ITMN) said it had resubmitted its pirfenidone New Drug Application to the FDA in response to a Complete Response Letter received in May 2010. Pirfenidone is being developed for the treatment of adult patients with idiopathic pulmonary fibrosis.
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July 21, 2014
11:19 EDTITMNInterMune July weekly volatility elevated
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July 17, 2014
12:42 EDTITMNInterMune receives FDA Breakthrough Therapy Designation for pirfenidone
InterMune announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. FDA. This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Pirfenidone is an investigational treatment for adult patients with idiopathic pulmonary fibrosis.

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