News
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AstraZeneca has announced top-line results from the Phase 3 KRONOS trial of its PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of moderate to severe COPD. Compared to Bevespi Aerosphere glycopyrronium/formoterol fumarate, Symbicort Turbuhaler budesonide/formoterol fumarate,… Read more . . .
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Theravance Biopharma and Mylan have announced that the NDA for revefenacin (TD-4208) inhalation solution for the treatment of COPD the companies submitted in November 2017 has been accepted for review by the FDA, with a… Read more . . .
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Aradigm Corporation has received a complete response letter from the FDA in response to its NDA for Linhaliq dual release inhaled ciprofloxacinfor the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the… Read more . . .
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According to GlaxoSmithKline and Innoviva, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding approval of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma that… Read more . . .
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Liquidia Technologies has presented preclinical and Phase 1 study results for its LIQ861 inhaled treprostinil for the treatment of pulmonary arterial hypertension at the Annual World Congress of the Pulmonary Vascular Research Institute (PVRI), noting… Read more . . .
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Hovione has announced the addition of a new MG2 Tekna capsule filler for filling DPI capsules at the company’s Loures, Portugal facilities. The MG2 Tekna machine, which has a capacity of up to 110,000 capsules/hour… Read more . . .
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The Icelandic Medicines Agency has approved an MAA filed by Medical Developments International (MVP) to allow marketing of Penthrox inhaled methoxyflurane for the treatment of pain due to traumatic injury. The company said that Penthrox… Read more . . .
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The UK Medicines and Healthcare Products Regulatory Agency has approved a Clinical Trial Application filed by Pulmatrix for a Phase 1/1b study of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary… Read more . . .
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Smartinhaler maker Adherium has opened a new corporate headquarters in San Mateo, California, the company said. In 2017, the company announced that it had sold more than 100,000 Smartinhaler inhaler monitoring systems. Adherium CEO Arik… Read more . . .
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Copley Scientific has announced the launch of the BAC 2100 Breath Actuation Controller for automated flow control during cascade impaction and delivered dose uniformity testing of metered dose inhalers. The company is also launching the… Read more . . .
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