Calls for papers
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US-based Avalyn Pharma has announced the appointment of former Aerami Therapeutics Chief Development Officer Melissa Rhodes as Chief Operating Officer, a newly created position. Avalyn, which is developing AP01 inhaled pirfenidone and AP02 inhaled nintedanib for… Read more . . .
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According to Verona Pharma, the FDA has accepted the company’s NDA for its nebulized ensifentrine (RPL554) for the treatment of COPD with a PDUFA target date of June 26, 2024. The company submitted the NDA… Read more . . .
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According to Liquidia Corporation, United Therapeutics has filed a new patent infringement suit in the US District Court for the District of Delaware in response to Liquidia’s submission of an sNDA for Yutrepia treprostinil DPI to add… Read more . . .
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According to Krystal Biotech, the FDA has granted orphan drug designation to the company’s KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin (AAT) deficiency. Krystal, which is also developing inhaled gene therapies for… Read more . . .
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Insmed announced that the Phase 3 ARISE study of Arikayce amikacin liposome inhalation suspension demonstrated the effectiveness of the QOL-B questionnaire for patient-reported outcomes. The ARISE study of Arikayce in patients with nontuberculous mycobacterial (NTM)… Read more . . .
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ENA Respiratory announced preparations for a Phase 2b study of its INNA-051 pegylated TLR2/6 agonist nasal spray for the prevention of respiratory viruses in people aged 65 and older will be supported by an additional $3.8… Read more . . .
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According to Orexo, the United States Patent and Trademark Office (USPTO) has issued the company US patent No. 11,737,980 (“Pharmaceutical composition for drug delivery”) which provides protection for OX640 epinephrine nasal powder. Orexo notes that… Read more . . .
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PureIMS has announced that it intends to initiate a dose-finding study of its Levodopa Cyclops DPI titled “A pilot open-label, randomized, crossover, comparative bioavailability study of levodopa administered via Levodopa Cyclops (test product) relative to… Read more . . .
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Immune Biosolutions has announced the publication of results from Phase 1 and 2 trials of the company’s IBIO123 inhaled antibody therapy in patients with COVID-19 in The Lancet Infectious Diseases. Immune Bio announced the initiation of… Read more . . .
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Propellant manufacturer Honeywell and CDMO Recipharm are partnering on development of MDIs formulated with Honeywell’s Solstice Air lower-GWP propellant, the companies said. Honeywell announced in October 2022 that it had started large scale manufacturing of… Read more . . .
Upcoming Events
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September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
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