Medical

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

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

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

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

According to Felix Biotechnology, Yale University researchers have initiated a Phase 1/2 trial of Felix's YPT-01 nebulized phage therapy for the treatment of chronic P. aeruginosa infections in cystic fibrosis patients. YPT-01 was initially formulated at Yale and licensed to Felix, a start-up founded by Yale Faculty. Felix recently signed a deal with TFF … [Read more...] about Phase 1/2 trial of inhaled phage therapy for the treatment of P. aeruginosa infections in CF patients gets underway

Insmed announced that the first patient has been dosed in a Phase 3b trial of its Arikayce amikacin liposome inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). Arikayce is delivered via the PARI Lamira nebulizer system. The FDA approved Arikayce for the treatment of NTM lung … [Read more...] about Insmed initiates Phase 3b clinical trial of Arikayce inhalation suspension for the treatment of NTM caused by MAC