Jobs
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The FDA has announced that it approved Eli Lilly and Company’s Baqsimi single-use intranasal dry powder glucagon for the emergency treatment of severe hypoglycemia. Lilly announced that it had submitted the NDA for Baqsimi in… Read more . . .
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Oyster Point Pharma has announced the initiation of the Phase 3 ONSET-2 study of its OC-01 nicotine acetylcholine receptor (nAChR) agonist nasal spray for the treatment of dry eye disease. In October 2018, the company… Read more . . .
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BlueWillow Biologics announced that it has been issued US patent No. 10,206,996, titled “Herpes simplex virus nanoemulsion vaccine,” covering an intranasal herpes simplex virus (HSV) vaccine based on its NanoVax adjuvant platform. The company is… Read more . . .
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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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Upcoming Events
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The Inhaled & Nasal Biologics | DNA Forum
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September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany



