Jobs
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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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Catalent will continue to offer DPI development and manufacturing services at the Nottingham, UK Juniper Pharma Services facility that was part of its recently completed acquisition of Juniper Pharmaceuticals, the company says. Catalent announced its… Read more . . .
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Evoke Pharma has announced that the FDA has accepted the company’s 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, which Evoke submitted in June… Read more . . .
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According to Circassia Pharmaceuticals, the FDA has accepted its NDA for the Duaklir aclidinium/formoterol DPI for the treatment of COPD and an sNDA for the Tudorza aclidinium bromide DPI, with a PDUFA date of March… Read more . . .
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Adherium recently received OTC clearance for its Hailie inhaler monitoring platform in the US, and the company says that it has now launched direct-to-consumer sales through a web site. Hailie includes an inhaler sensor and… Read more . . .
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Acorda Therapeutics has announced that Chief Technology Officer Rick Batycky is leaving the company as of August 20, 2018 to head up a new private biotech firm. Batycky co-founded Civitas Therapeutics, which was acquired by… Read more . . .
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US-based Onspira Therapeutics has announced that its OSP-101, an inhaled interleukin-1 receptor antagonist (IL-1Ra) for the treatment of bronchiolitis obliterans, has been granted orphan drug designation by the FDA. Onspira is a private company created… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA