December 2016
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Anoro umeclidinium/vilanterol for the treatment of COPD, GlaxoSmithKline and Theravance have announced. The dosage would be 55 mcg/22… Read more . . .
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Sad Diego-based CURx Pharmaceuticals has announced a global license agreement with Gilead Sciences for development of Fosfomycin/Tobramycin for Inhalation (FTI) to treat Pseudomonas aeruginosa lung infection in cystic fibrosis (CF) patients. Gilead initiated a Phase… Read more . . .
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Insmed says that it is pleased with results from its ongoing CLEAR-110 extension study of Arikace inhaled liposomal amikacin for the treatment of P. aeruginosa infections in cystic fibrosis patients. Data from 98 patients who… Read more . . .
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Lupin Pharmaceuticals has announced that Maurice Chagnaud has joined the company as President, Europe and Head of Inhalation Strategy. He was most recently Senior Vice President, Central & Eastern Europe at Teva. Chagnaud’s responsibilities will… Read more . . .
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Actavis will acquire Forest Laboratories in a deal worth approximately $25 billion, the companies have announced. Both boards of directors have approved the agreement. Forest’s products include the Tudorza Pressair aclidinium bromide DPI, which launched… Read more . . .
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Ben Venue Laboratories has voluntarily recalled a single lot of 30 ml vials of acetylcysteine 10% inhalation solution due to a glass particle visible in one of the vials. The recall affects lot #2005479 which… Read more . . .
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Sandoz has recently announced the approval of the AirFluSal Forspiro salmeterol/fluticasone DPI by Norway and Bulgaria, bringing the total number of European approvals to 7. The inhaler has also been approved in Denmark, Germany, Sweden,… Read more . . .
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Insmed has announced that the EMA’s Committee for Orphan Medicinal Products has issued a positive opinion regarding orphan designation for Insmed’s Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The… Read more . . .
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Mast Therapeutics has announced that it will acquire Aires Pharmaceuticals, which is developing a sodium nitrite inhalation solution for the treatment of pulmonary arterial hypertension. The inhalation solution, known as AIR001 or “Aironite,” has received… Read more . . .
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Skyepharma has announced the launch of Flutiform fluticasone/formoterol MDI for the treatment of asthma in France. Mundipharma will market the inhaler in 50/5 µg and 125/5 µg versions. The launch triggers a €3.0 million milestone… Read more . . .
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