United Therapeutics announced that its BREEZE study has demonstrated that patients with pulmonary arterial hypertension (PAH) who use Tyvaso treprostinil inhalation solution can safely switch to the Tyvaso treprostinil DPI. The company also announced that a PK study in healthy volunteers showed that the treprostinil exposure from Tyvaso DPI was comparable to that of … [Read more...] about Study demonstrates that patients can switch successfully from Tyvaso inhalation solution to Tyvaso DPI
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Pneumagen raises £2.5 million for clinical development of Neumifil nasal spray against flu, RSV, and COVID-19
University of St Andrews spin out Pneumagen said that it has raised £2.5 million for clinical development of its Neumifil intranasal carbohydrate binding module (mCBM) for the prevention and treatment of respiratory viruses, including flu, RSV, and COVID-19. The company says that it previously raised £4 million investment for development of Neumifil, which is … [Read more...] about Pneumagen raises £2.5 million for clinical development of Neumifil nasal spray against flu, RSV, and COVID-19
First patients dosed in Meissa’s Phase 2 trial of its intranasal vaccine against RSV
Meissa Vaccines said that it has started dosing participants in its Phase 2 trial of MV-012-968 intranasal live attenuated vaccine candidate against respiratory syncytial virus (RSV). MV-012-968 is based on Meissa's AttenuBlock platform, which it says is designed for "creating safe, potent, stable, and cost-effective intranasal vaccines." The Phase 2 virus challenge … [Read more...] about First patients dosed in Meissa’s Phase 2 trial of its intranasal vaccine against RSV
FDA accepts Impel’s NDA for INP104 intranasal DHE for the treatment of migraines
According to Impel NeuroPharma, the FDA has accepted the company's 5O5(b)(2) NDA for its INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of migraine headaches and has set a PDUFA goal date of September 6, 2021. The agency has also conditionally accepted the trade name "Trudhesa." Impel submitted the NDA for INP104, its first US regulatory … [Read more...] about FDA accepts Impel’s NDA for INP104 intranasal DHE for the treatment of migraines
Synairgen initiates Phase 3 trial of inhaled interferon beta-1a in hospitalized COVID-19 patients
Synairgen said that the first patient has been dosed in the Phase 3 SG018 trial of its SNG001 inhaled interferon beta-1a in hospitalized COVID-19 patients, with the SG018 study expected to enroll 610 COVID-19 patients at sites in 20 countries. A Phase 2 study of SNG001 in non-hospitalized patients is also underway, the company said. In July 2020, Synairgen … [Read more...] about Synairgen initiates Phase 3 trial of inhaled interferon beta-1a in hospitalized COVID-19 patients
UC Davis spin out InVixa to develop inhaled statins for the treatment of COVID-19
A new spin out from the University of California, Davis called InVixa announced that it has acquired the rights to UC Davis intellectual property related to delivery of statins to the lung for the treatment of viral respiratory infections, including COVID-19. InVixa said that it expects to select a lead candidate following pre-clinical studies early this year and … [Read more...] about UC Davis spin out InVixa to develop inhaled statins for the treatment of COVID-19
BreatheSuite raises $1.2 million for continued development of inhaler monitoring systems
Canadian inhaler tracking and training start-up BreatheSuite has announced the completion of a $1.2 million financing round and said that it intends to use the funds for expanded distribution of its MDI add-on device in North America and for development of additional inhaler tracking products. The company conducted patient testing of its MDI add-on and associated app … [Read more...] about BreatheSuite raises $1.2 million for continued development of inhaler monitoring systems
Phase 2 study of Seelos’s intranasal racemic ketamine for suicidal ideation gets underway
Seelos Therapeutics announced that the first patients have been dosed in a Phase 2 study of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. In November 2019, Seelos announced that it had been granted Fast Track designation for SLS-002 for this indication, and in January 2020, … [Read more...] about Phase 2 study of Seelos’s intranasal racemic ketamine for suicidal ideation gets underway
Copley Scientific launches e-training on OINDP testing methods
Copley Scientific has announced the launch of an e-training service that allows customers to get live-streamed instruction in the use of OINDP testing equipment for in vitro testing. Both standard e-training packages and custom live-streamed instruction are available; topics include installation qualification and operational qualification (IQ/OQ) as well as … [Read more...] about Copley Scientific launches e-training on OINDP testing methods
Odyssey acquired intranasal therapy for the treatment of mild traumatic brain injury from Prevacus
Odyssey Group International said that it has signed a definitive agreement with Prevacus to acquire PRV-002, an intranasal therapy for the treatment of mild traumatic brain injury. As part of the deal, Prevacus CEO Jake Vanlandingham will join Odyssey. In 2017, Prevacus announced that it planned to initiate a Phase 1 trial of PRV-002; however, Prevacus has been … [Read more...] about Odyssey acquired intranasal therapy for the treatment of mild traumatic brain injury from Prevacus