News
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Acorda Therapeutics will present data from a Phase 1 study of its CVT-427 zolmitriptan DPI at the Annual Scientific Meeting of the American Headache Society, the company has announced. According to the company, the data… Read more . . .
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Insmed has announced the withdrawal of its marketing authorization application for Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The MAA was submitted to the European Medicines Agency in 2014,… Read more . . .
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Chiesi says that it is on track with planned regulatory submissions in the EU for its ICS/LAMA/LABA MDI for the treatment of COPD by the end of 2016 after successful completion of two 12-month Phase… Read more . . .
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Spray-drying and DPI specialist Hovione announced the opening a new sales and customer support office in Osaka, Japan, saying that “The new office underlines the importance of Japan for Hovione’s business activities. Japan is a… Read more . . .
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GlaxoSmithKline plc (LSE:GSK) and Innoviva have announced that the planned submission of an NDA for a triple therapy DPI for the treatment of COPD has been moved up from the first half of 2018 to… Read more . . .
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California-based Innovus Pharmaceuticals announced that it has signed a manufacturing agreement for its FlutiCare fluticasone propionate nasal spray in anticipation of FDA approval, which it expects in the 3rd quarter of 2016. No details were… Read more . . .
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According to Teva Pharmaceutical, a decentralized procedure for its Braltus tiotropium bromide DPI for the treatment of COPD has reached “a positive conclusion.” The tiotropium formulation is delivered using the new Zonda inhaler, the company… Read more . . .
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Perrigo and Hikma subsidiary West-Ward Pharmaceuticals have launched an OTC fluticasone propionate nasal spray, a generic version of Flonase, in the US after receiving approval for the product from the FDA, the companies said. The… Read more . . .
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Pulmatrix has announced the completion of a Phase 1 pharmacokinetic study of its PUR0200 generic tiotropium DPI in healthy volunteers. Pulmatrix announced the initiation of the study in February 2016. The company has partnered with… Read more . . .
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GlaxoSmithKline and Innoviva (formerly Theravance, Inc.) have announced data from the Salford Lung Study (SLS) showing that COPD patients using the Relvar Ellipta 100/25 mcg fluticasone furuoate/vilanterol DPI had an 8.41% lower rate of moderate… Read more . . .
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