According to an Insmed update, the company launched recently launched Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in Japan. The Japanese Ministry of Health, Labour and Welfare approved Arikayce for that indication in March 2021. The company also … [Read more...] about Insmed launches Arikayce in Japan, advances TPIP into Phase 2 trials
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Satsuma initiates new Phase 3 trial of STS101 intranasal DHE powder for migraine
Satsuma Pharmaceuticals has initiated the SUMMIT Phase 3 trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine, the company said. A previous Phase 3 trial of STS101 called EMERGE failed to meet its primary endpoints. Topline data from the SUMMIT trial are expected in the second half of 2022. The SUMMIT trial is expected to enroll … [Read more...] about Satsuma initiates new Phase 3 trial of STS101 intranasal DHE powder for migraine
In vitro tests show Augmenta/TFF dry powder mAb neutralizes SARS-C0V-2 Delta variant
Augmenta Bioworks and TFF Pharmaceuticals have announced that in vitro testing of their AUG-3387 dry powder monoclonal antibody has demonstrated that the mAb neutralizes the SARS-CoV-2 Delta variant, the highly transmissible strain that is currently dominant in numerous countries. In vitro tests had already demonstrated that the mAb could be effective against other … [Read more...] about In vitro tests show Augmenta/TFF dry powder mAb neutralizes SARS-C0V-2 Delta variant
Positive results for Phase 1 trial of CanSinoBio inhaled COVID-19 vaccine
Results from a Phase 1 trial of an inhaled version of CanSino Biologic's Ad5-nCoV vaccine against COVID-19 have been published online in The Lancet Infectious Diseases. The study enrolled 130 healthy volunteers who got either intramuscular Ad5-nCoV, two doses of aerosolized vaccine, or IM vaccine with an aerosolized booster and found that the nebulized vaccine was … [Read more...] about Positive results for Phase 1 trial of CanSinoBio inhaled COVID-19 vaccine
Inhaled dry powder tamibarotene effective against respiratory viruses in preclinical studies
Preclinical studies by researchers from the LKS Faculty of Medicine at The University of Hong Kong have demonstrated that a dry powder formulation of tamibarotene delivered to the lungs of hamster and mice has broad activity against respiratory viruses, including SARS-CoV-2, MERS-CoV, and influenza A H1N1. Results from the studies were published in Advanced … [Read more...] about Inhaled dry powder tamibarotene effective against respiratory viruses in preclinical studies
Sorrento initiates Phase 2 trial of its intranasal neutralizing antibody against COVID-19
Sorrento Therapeutics has initiated a Phase 2 trial of its CoviDrops intranasal neutralizing antibody in COVID-19 patients in the UK, the company said. The trial is expected to enroll 350 COVID-19 patients who have mild symptoms or are asymptomatic who will get either 10 mg or 20 mg of CoviDrops via nasal instillation or placebo. Treatment and assessment will take … [Read more...] about Sorrento initiates Phase 2 trial of its intranasal neutralizing antibody against COVID-19
Celltrion, Inhalon partner on inhaled regdanvimab for COVID-19
Inhalon Biopharma has announced that it is partnered with Celltrion to develop a nebulized formulation of regdanvimab, a monoclonal antibody for the treatment of COVID-19, which will be known as IN-006. In May 2021, Inhalon announced that it had been awarded a US Army contract worth $7 million for development of IN-006. The company says that a Phase 1 study of IN-006 … [Read more...] about Celltrion, Inhalon partner on inhaled regdanvimab for COVID-19
Meissa announces results of preclinical testing of its intranasal COVID-19 vaccine, Phase 1 trial update
Meissa Vaccines said that a SARS-CoV-2 challenge test of its MV-014-212 intranasal live attenuated vaccine candidate in non-human primates demonstrated similar efficacy for a single dose compared to currently available vaccines, and the intranasal vaccine stimulated both mucosal and systemic antibodies. According to the company, the vaccine generated antibodies able … [Read more...] about Meissa announces results of preclinical testing of its intranasal COVID-19 vaccine, Phase 1 trial update
AIM ImmunoTech announces planned human challenge trial of intranasal Ampligen against rhinovirus and flu
AIM ImmunoTech has announced a planned Phase 2a human challenge trial of intranasal Ampligen rintatolimod against human rhinovirus and influenza. The company suggested that "Success against these common viruses could also indicate that an Ampligen prophylaxis could help blunt the spread of infection from lethal coronaviruses, as well as other serious viruses." The … [Read more...] about AIM ImmunoTech announces planned human challenge trial of intranasal Ampligen against rhinovirus and flu
Opiant announces positive results from PK study of OPNT003 intranasal nalmefene
Opiant Pharmaceuticals said that a PK study of its OPNT003 intranasal nalmefene, which it is developing for opioid overdose, demonstrated that the Tmax of the nasal formulation was about 15 minutes, similar to that shown in a previous pilot study, and Cmax was slightly higher than for an intramuscular injection of nalmefene and higher than in the pilot study. The … [Read more...] about Opiant announces positive results from PK study of OPNT003 intranasal nalmefene