News
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Oxford Science Enterprises and Harrington Discovery Institute at University Hospitals, together with the University of Edinburgh’s Old College Capital venture investment fund, have created a startup called AlveoGene to develop inhaled gene therapies based on… Read more . . .
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US-based CDMO Renaissance Lakewood, which offers a wide range of services for nasal spray development and manufacturing, has announced a significant expansion of its laboratories in New Jersey, the company said. The expansion is part… Read more . . .
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Copley Scientific has announced the launch of its new Patient Exhalation Simulator (PES) for use in dry powder inhaler development. According to Copley, the PES simulates exhalation into a DPI prior to inhalation of the… Read more . . .
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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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