December 2016
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Glenmark Pharmaceuticals said that it has acquired an exclusive license to market a generic tiotropium bromide dry powder inhaler in Western Europe. The DPI, a generic version of Boehringer Ingelheim’s Spiriva Handihaler for the treatment… Read more . . .
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insys Therapeutics’ epinephrine nasal spray for the treatment of anaphylaxis has received Fast Track designation from the FDA, the company said. In June 2018, Insys said that a Phase 1 study of the nasal spray… Read more . . .
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Medical Developments International (MVP), which announced in July 2018 that it was expecting a clinical hold letter from the FDA regarding its US clinical program for its Penthrox methoxyflurane inhaler, said that it has now… Read more . . .
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Device developer Iconovo AB has announced the appointment of Mikael Ekström as its new VP, Development effective September 1, 2018. Ekström held various positions at AstraZeneca over a period of almost 30 years, most recently… Read more . . .
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Product Quest manufacturing, which recently announced a recall of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa, has now recalled all of the nasal products it… Read more . . .
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Impel NeuroPharma said that the first subject has been dosed in a Phase 1 study of INP105 intranasal dry powder olanzapine, which the company is developing for the treatment of acute agitation in bipolar I… Read more . . .
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AstraZeneca has announced that the Phase 3b AERISTO trial of Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for moderate to very severe COPD failed to meet 2 out of 3 of its primary endpoints, including non-inferiority to… Read more . . .
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The FDA has granted fast track designation to NeuroproteXeon (NPXe) and Mallinckrodt’s inhaled xenon gas for the treatment of post-cardiac arrest syndrome (PCAS), the companies said. A Phase 3 trial of inhaled xenon for that… Read more . . .
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Impel NeuroPharma said that the Phase 3 STOP-301 safety and tolerability study of INP104 intranasal dihydroergotamine (DHE) for the treatment of migraine has gotten underway, with the first patient dosed. The company announced plans for… Read more . . .
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Vectura has announced results from a pharmacokinetic study of its VR647 nebulized budesonide inhalation suspension in asthma patients aged 4 to 8 and a methodology study of the use of a mouthpiece with the VR647… Read more . . .
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