According to Ji Xing Pharmaceuticals, Chinese regulators have approved the company's application for a Phase 3 clinical trial of OC-01 varenicline nasal spray for the treatment of dry eye disease in China. Ji Xing acquired the Chinese rights to OC-01 and OC-02 simpinicline nasal spray for the treatment of dry eye disease from Oyster Point Pharma in August 2021. In the … [Read more...] about Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
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Consortium partners with RocketVax on intranasal COVID-19 vaccine development
A Swiss-German consortium led by Volker Thiel of the Institute of Virology and Immunology and the University of Bern has partnered with Swiss startup RocketVax to develop two live attenuated intranasal vaccine candidates against SARS-CoV-2 for planned Phase 1 trials. The consortium, which also includes researchers from the University of Geneva, the Freie Universität … [Read more...] about Consortium partners with RocketVax on intranasal COVID-19 vaccine development
Positive Phase 1b results for Pulmatrix’s PUR1800 inhaled narrow spectrum kinase inhibitor
Pulmatrix has announced that topline data from a Phase 1b study of its PUR1800 dry powder narrow spectrum kinase inhibitor in COPD patients showed that inhaled PUR1800 produced "low and consistent systemic exposure" with "no observed safety signals" In January 2020, when Pulmatrix announced a license agreement with the Lung Cancer Initiative at Johnson & Johnson … [Read more...] about Positive Phase 1b results for Pulmatrix’s PUR1800 inhaled narrow spectrum kinase inhibitor
TFF partners with US army on intranasal dry powder vaccine against SARS-CoV-2
TFF Pharmaceuticals said that the company has entered into an additional Cooperative Research and Development Agreement (CRADA) with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Geneva Foundation for formulation of an intranasal dry powder recombinant vesicular stomatitis virus (rVSV) against SARS-CoV-2 using … [Read more...] about TFF partners with US army on intranasal dry powder vaccine against SARS-CoV-2
University of Liverpool partners with Aerogen on development of inhaled antimicrobials
Researchers from the University of Liverpool have partnered with nebulizer maker Aerogen on a project called "Treatment of Respiratory Infections with inhaled AntimicrobiaLs" (TRIAL), which will develop inhaled therapies for the treatment of bacterial and viral pulmonary infections in hospitalized patients. Funding for the £1.3million project comes from the … [Read more...] about University of Liverpool partners with Aerogen on development of inhaled antimicrobials
Positive Phase 3 results for Optinose’s Xhance intranasal fluticasone propionate for chronic sinusitus
According to Optinose, the Phase 3 ReOpen1 trial of Xhance intranasal fluticasone propionate (OPN-375) in patients with chronic sinusitus met both of its primary endpoints, demonstrating statistically significant reduction in symptoms and in sinus inflammation measured by CT scan compared to placebo. A second Phase 3 trial, ReOpen2, is underway, with results expected … [Read more...] about Positive Phase 3 results for Optinose’s Xhance intranasal fluticasone propionate for chronic sinusitus
Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin
Tonix Pharmaceuticals has provided updates on two formulations of its intranasal potentiated oxytocin. The company acquired the license for one of the formulations, TNX-1900 for the treatment of migraine, from Trigemina in June 2020. According to the announcement, Massachusetts General Hospital will conduct a Phase 2 trial of TNX-1900 for the treatment of binge … [Read more...] about Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin
FDA lifts clinical hold on Penthrox methoxyflurane inhaler
According to Medical Developments International (MVP), the FDA has lifted a clinical hold on MVP's Penthrox methoxyflurane inhaler and, as a result, MVP is now preparing a Phase 3 trial of Penthrox for trauma pain that is expected to begin recruiting by the end of this year. The FDA issued the clinical hold letter to MVP in 2018, and MVP said in July 2019 that it … [Read more...] about FDA lifts clinical hold on Penthrox methoxyflurane inhaler
FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail
Sorrento Therapeutics announced that the FDA has given the company the okay to move ahead with a Phase 1 trial of its Covishield (STI-9199) intranasal antibody cocktail in healthy volunteers. According to Sorrento, in vitro and in vivo studies of STI-9199 have demonstrated that the antibody cocktail has activity against multiple variants of SARS-CoV-2, including three … [Read more...] about FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail
Intranasal COVID-19 booster elicits mucosal immunity and protects against infection in preclinical studies
BlueWillow Biologics and Medigen Vaccine Biologics Corporation (MVC) have announced that a preclinical study of their BW-1019 intranasal COVID-19 booster demonstrated that giving the nasal vaccine after intramuscular vaccination induced neutralizing antibodies and protected against disease in a hamster model. According to the companies, no detectable virus was found … [Read more...] about Intranasal COVID-19 booster elicits mucosal immunity and protects against infection in preclinical studies