Gilead Sciences Chairman and CEO Daniel O'Day has announced that the company has received FDA approval for a Phase 1 trial of inhaled remdesivir and will initiate the study within a week. Trials of the inhaled antiviral formulation in COVID-19 patients are expected to begin in August 2020. O'Day said, "Remdesivir, our investigational antiviral medicine, is … [Read more...] about Gilead announces Phase 1 trial of inhaled remdesivir
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Preclinical study demonstrates potential of IntraVacc intranasal pertussis vaccine
Vaccine developer Intravacc has published data from a preclinical study of an intranasal whooping cough vaccine demonstrating strong immune responses in mice. The intranasal vaccine also prevented colonization of the lung, trachea, and nose by B. pertussis, the bacteria that causes whooping cough, while mice vaccinated by subcutaneous injection did experience nasal … [Read more...] about Preclinical study demonstrates potential of IntraVacc intranasal pertussis vaccine
Positive Phase 3 results for Impel’s INP104 intranasal DHE for the treatment of migraine
Impel NeuroPharma has announced that the Phase 3 STOP 301 study of INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of acute migraine met its primary objectives, with 66.3% of patients experiencing pain relief and 38% experiencing freedom from pain two hours post dose. Pain relief began as early as 15 minutes post dose for 16.3% of patients using … [Read more...] about Positive Phase 3 results for Impel’s INP104 intranasal DHE for the treatment of migraine
Phase 3 trial of Enerzair Breezhaler for uncontrolled asthma meets primary endpoint
Novartis has announced results from the Phase 3b ARGON study of Enerzair Breezhaler (QVM149) indacaterol/glycopyrronium/mometasone for the treatment of uncontrolled asthma, with the data published in the journal Respiratory Medicine. The 24-week study met its primary endpoint, demonstrating non-inferiority of high and medium doses of once-daily Enerzair Breezhaler to … [Read more...] about Phase 3 trial of Enerzair Breezhaler for uncontrolled asthma meets primary endpoint
Intravacc, Wageningen Bioveterinary Research, and Utrecht University partner on intranasal COVID-19 vaccine
Dutch vaccine maker Intravacc has announced that it is partnering with Wageningen Bioveterinary Research (WBVR) and Utrecht University on development of an intranasal Newcastle disease virus (NDV) vector vaccine for the prevention of COVID-19 in humans. The company said that its Vero cell platform, which is FDA approved, would serve as the basis for a scalable … [Read more...] about Intravacc, Wageningen Bioveterinary Research, and Utrecht University partner on intranasal COVID-19 vaccine
Phase 2a trial of Novus’s OP0201 nasal MDI for otitis media fails to meet primary endpoints
Novus Therapeutics said that a Phase 2a clinical trial of its OP0201 intranasal surfactant MDI for the treatment of acute otitis media in infants and children failed to meet its primary endpoints of "resolution of bulging tympanic membrane at visit 2 and resolution of middle ear effusion at visit 3." The study did show greater resolution of middle ear effusion for … [Read more...] about Phase 2a trial of Novus’s OP0201 nasal MDI for otitis media fails to meet primary endpoints
Altimmune announces initiation of Phase 1/2 trial of T-COVID intranasal therapy for COVID-19
Altimmune announced that the FDA has approved the company's IND for a Phase 1/2 clinical trial of its T-COVID intranasal therapy for the treatment of COVID-19, with data expected to be available in the fourth quarter of 2020. Earlier this year, Altimmune announced a partnership with the University of Alabama Birmingham for development of an intranasal vaccine for … [Read more...] about Altimmune announces initiation of Phase 1/2 trial of T-COVID intranasal therapy for COVID-19
Atossa Therapeutics announces development of intranasal therapy for mild COVID-19
Atossa Therapeutics announced that it has signed an agreement with Summit Biosciences for development and manufacturing of an intranasal formulation of Atossa's AT-301 as a candidate for the treatment of mild COVID-19, and it plans to submit an IND for clinical trials expected to begin in the third quarter of this year. The company said it is also investigating the … [Read more...] about Atossa Therapeutics announces development of intranasal therapy for mild COVID-19
Covis announces initiation of Phase 3 US trial of Alvesco ciclesonide MDI for the treatment of COVID-19
Covis Pharma said that it has initiated a Phase 3 of Alvesco ciclesonide MDI for the treatment of COVID-19 in US patients aged 12 and older who have not been hospitalized, with preliminary results expected in late-August/early-September 2020. According to Covis, studies of Alvesco for COVID-19 are already underway in Australia, Japan, South Korea, Sweden, and the … [Read more...] about Covis announces initiation of Phase 3 US trial of Alvesco ciclesonide MDI for the treatment of COVID-19
Teva Canada imports supply of UK-branded salbutamol (albuterol) MDIs under interim order
Teva Canada said that it has imported a 4-week supply of Salamol salbutamol (albuterol) sulfate MDIs through Teva UK under an interim order by the Minister of Health in response to shortages of the inhalers in Canada caused by the COVID-19 pandemic. Salamol MDIs are marketed by IVAX Pharmaceuticals in the UK; Teva acquired IVAX in 2006. Health Canada recently … [Read more...] about Teva Canada imports supply of UK-branded salbutamol (albuterol) MDIs under interim order