August 2012
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The FDA has issued a final guidance titled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff” that specifies how to comply with postmarketing safety reporting (PMSR) requirements for combination products issued in 2016.… Read more . . .
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Penthrox methoxyflurane inhaler maker Medical Developments International said that it recently met with the FDA regarding the agency’s August 2018 clinical hold letter on Penthrox, and the company now has a path forward to resolve… Read more . . .
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Aridis Pharmaceuticals said that the EMA has granted orphan drug designation to the company’s AR-501 inhaled gallium citrate for the treatment of pulmonary infections in cystic fibrosis patients. The company said that the FDA had… Read more . . .
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In a business update, Vectura Group said that the company is focusing its R&D strategy on partnerships for development of its inhaled drug candidates. The company also said that it is considering how to structure a… Read more . . .
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The FDA has approved low, medium, and high dose versions of Teva’s AirDuo Digihaler fluticasone propionate/salmeterol digital DPI for the treatment of asthma, the company said. The inhaler should be available in the US sometime next… Read more . . .
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Inhaled drug developer MannKind Corporation announced that the company has expanded its capacity for commercial manufacturing of highly potent dry powder formulations at its facility in Danbury, Connecticut, USA. The new manufacturing suite includes bulk… Read more . . .
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DPI developer Iconovo has announced that a PK study of its ICOres reservoir-based inhaler demonstrated that the device delivered a budesonide/formoterol dry powder formulation as expected compared to Symbicort Turbuhaler. According to the company, the… Read more . . .
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AZTherapies, which is developing an inhaled cromolyn sodium/ibuprofen formulation, has named Jay Mohr as Chief Operating Officer, Chief Business Officer, and Head of Commercial Development. Mohr was most recently co-founder and Managing Director of Locust… Read more . . .
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Pulmatrix has announced the initiation of a Phase 2 clinical trial of Pulmazole inhaled itraconazole (PUR1900) for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma, with top line data expected in mid 2020.… Read more . . .
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Submit 200-word podium abstracts by August 1, 2019 at https://www.rddonline.com/rdd/speaker_reg.php?id=18 Preliminary topics for RDD 2020 include: Targeting New Pathologies Personalized Aerosol Therapy Digital Health & Real World Data Advancing Inhaled and Nasal Science Effects of Evolving Global… Read more . . .
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