Transpire Bio, which launched in 2022 to develop inhaled therapeutics for both local and systemic delivery, has officially opened its new headquarters and research facility in Weston, FL, USA. Shortly after launching, the company announced deals with Recipharm for development of 4 inhaled formulations (TRB-1, TRB-2, TRB-3, and TRB-4) and with INTO for 3 additional … [Read more...] about Transpire Bio opens new headquarters and research facility
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MannKind gets US patent covering clofazimine inhalation suspension
According to MannKind Corporation, the United States Patent and Trademark Office (USPTO) has issued US patent No. 11,793,808 ("Compositions of Clofazimine, Combinations Comprising Them, Processes for Their Preparation, Uses and Methods Comprising Them"), which covers the company's MNKD-101 clofazimine inhalation suspension, until 2039. MannKind is developing MNKD-101 … [Read more...] about MannKind gets US patent covering clofazimine inhalation suspension
University of Sydney researchers get $687,000 in FDA funding for development of in vitro testing methods for DPIs
Researchers at the University of Sydney have been awarded $687,000 by the FDA to support a project titled, "Development of a laser-based testing platform for generic dry powder inhaler DPI evaluation and in-silico model validation," the university said. The project is led by Hak-Kim Chan of the Sydney Pharmacy School and Agisilaos Kourmatzis of the School of … [Read more...] about University of Sydney researchers get $687,000 in FDA funding for development of in vitro testing methods for DPIs
FDA accepts AstraZeneca’s sBLA for self-administration of FluMist Quadrivalent intranasal flu vaccine
According to AstraZeneca, the FDA has accepted for review the company's supplemental biologics license application (sBLA) for self-administration of FluMist Quadrivalent nasal spray vaccine against influenza. AstraZeneca says that it expects a PDUFA date in the first quarter of 2024, which would allow for self administration of FluMist for the 2024-25 flu season if … [Read more...] about FDA accepts AstraZeneca’s sBLA for self-administration of FluMist Quadrivalent intranasal flu vaccine
Defender announces that NASA will conduct 2 Phase 2 trials of DPI-386 intranasal scopolamine
Researchers at the United States National Aeronautics and Space Administration (NASA) will lead 2 Phase 2 studies of Defender Pharmaceuticals' DPI-386 scopolamine nasal gel for the prevention of motion sickness induced by sudden changes in gravitoinertial forces (g-transitions) such as those experienced by astronauts. The FDA recently accepted Defender's NDA for … [Read more...] about Defender announces that NASA will conduct 2 Phase 2 trials of DPI-386 intranasal scopolamine
Milestone submits NDA for etripamil nasal spray for the treatment of PVST
Milestone Pharmaceuticals said that it has submitted an NDA for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and that the FDA has conditionally approved the proposed trade name "Cardamyst." The company said that it is continuing preparations for an anticipated commercial launch. According to Milestone, the clinical … [Read more...] about Milestone submits NDA for etripamil nasal spray for the treatment of PVST
Beckley Psytech initiates Phase 2b study of BPL-003 intranasal mebufotenin for treatment resistant depression
Beckley Psytech has announced the initiation of a Phase 2b trial of BPL-003 intranasal synthetic 5-MeO-DMT (mebufotenin) in people with moderate-to-severe treatment resistant depression. In February 2023, the company announced that the FDA approved an IND for the study. A Phase 2a trial of BPL-003 is still underway, Beckley said. The Phase 2b study is expected to … [Read more...] about Beckley Psytech initiates Phase 2b study of BPL-003 intranasal mebufotenin for treatment resistant depression
Qnovia partners with University of Virginia for development of inhaled antimicrobial peptides
Qnovia (formerly Respira Technologies) has announced a partnership with researchers at the University of Virginia (UVA) for the development of two new antimicrobial peptides for delivery via the company's RespiRx vibrating mesh nebulizer technology. The new candidates will be called QN-05, which will be developed for the treatment of pneumonia, and QN-06, for the … [Read more...] about Qnovia partners with University of Virginia for development of inhaled antimicrobial peptides
FDA okays home dosing of Tiziana’s intranasal foralumab for MS patients in expanded access program
According to Tiziana Life Sciences, the FDA is allowing patients with multiple sclerosis who are taking part in an expanded access program through Brigham and Women's Hospital to use intranasal foralumab at home instead of at the hospital. In April 2022, the company announced that the agency had agreed to allow the access program to expand to a total of 10 patients … [Read more...] about FDA okays home dosing of Tiziana’s intranasal foralumab for MS patients in expanded access program
Aculys says it will file NDA based on interim analysis of Japanese Phase 3 trial of NRL-1 (Valtoco) diazepam nasal spray
Aculys Pharma says that it plans to move ahead with submission of a marketing application to Japanese authorities based on interim data showing that a Japanese Phase 3 clinical study of NRL-1 diazepam nasal spray in epilepsy patients aged 6 to 17 met its primary efficacy endpoint. Aculys acquired development and commercialization rights to Neurelis's NRL-1 diazepam … [Read more...] about Aculys says it will file NDA based on interim analysis of Japanese Phase 3 trial of NRL-1 (Valtoco) diazepam nasal spray