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 a lentivirus platform technology licensed from the UK Respiratory Gene Therapy Consortium (GTC). The new … [Read more...] about Startup AlveoGene to develop inhaled gene therapies
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Renaissance Lakewood announces major spray lab expansion
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 of a larger relocation and upgrade project initiated in 2021 and expected to be completed by early next year. According to Renaissance, … [Read more...] about Renaissance Lakewood announces major spray lab expansion
Copley Scientific launches new patient exhalation simulator for DPI development
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 dose, a type of misuse that can significantly affect delivery of the full dose and which may occur with more than 20% of patients. The company … [Read more...] about Copley Scientific launches new patient exhalation simulator for DPI development
Melissa Rhodes joins Avalyn Pharma as Chief Operating Officer
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 the treatment of pulmonary fibrosis, recently announced the appointment of Howard Lazarus as Chief Medical … [Read more...] about Melissa Rhodes joins Avalyn Pharma as Chief Operating Officer
FDA accepts Verona’s NDA for nebulized ensifentrine for the treatment of COPD
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 for ensifentrine, a PDE3/PDE4 inhibitor, at the end of June 2023. Verona is also developing DPI and MDI formulations of ensifentrine. Verona … [Read more...] about FDA accepts Verona’s NDA for nebulized ensifentrine for the treatment of COPD
United Therapeutics files new suit alleging that Liquidia’s Yutrepia treprostinil DPI infringes a patent covering Tyvaso
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 pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication. Yutrepia was tentatively approved … [Read more...] about United Therapeutics files new suit alleging that Liquidia’s Yutrepia treprostinil DPI infringes a patent covering Tyvaso
Krystal Biotech gets orphan drug designation for KB408 inhaled gene therapy for AAT deficiency
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 the treatment of cystic fibrosis (KB407) and solid tumors (KB707), says that KB408 is intended to deliver 2 copies of the … [Read more...] about Krystal Biotech gets orphan drug designation for KB408 inhaled gene therapy for AAT deficiency
Insmed announces results of the Phase 3 ARISE study of Arikayce for NTM lung infections caused by MAC
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) lung infection caused by Mycobacterium avium complex (MAC) was initiated in December 2020 with the … [Read more...] about Insmed announces results of the Phase 3 ARISE study of Arikayce for NTM lung infections caused by MAC
ENA Respiratory announces new funding, personnel to support Phase 2b study of INNA-051 antiviral nasal spray
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 million from the US Department of Defense (DOD) as well as by several new clinical appointments. In January 2023, the company said that it had … [Read more...] about ENA Respiratory announces new funding, personnel to support Phase 2b study of INNA-051 antiviral nasal spray
Orexo gets US patent related to its OX640 intranasal dry powder epinephrine
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 it also received a European patent covering OX640 in 2022. The company announced Phase 1 results for OX640 in October … [Read more...] about Orexo gets US patent related to its OX640 intranasal dry powder epinephrine