Atossa Therapeutics said that it has gotten the go-ahead for a Phase 1 clinical study of its AT-301 nasal spray, which the company is developing for the treatment of COVID-19, and expects to begin enrollment within a month. Atossa previously announced that it had contracted with Summit Biosciences for development and manufacturing of the nasal spray and with Advance … [Read more...] about Atossa gets approval for Phase 1 study of AT-301 nasal spray
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TFF says dosing complete in Phase 1 trial of its dry powder voriconazole
TFF Pharmaceuticals said that the final subject has been dosed in a Phase 1 SAD/MAD study of its voriconazole inhalation powder, which the company is developing for the treatment of invasive pulmonary aspergillosis (IPA). The SAD/MAD study was initiated in November 2019, and the company recently announced topline safety results from the trial. TFF President and … [Read more...] about TFF says dosing complete in Phase 1 trial of its dry powder voriconazole
Milestone Pharmaceuticals raises $25 million, provides update on etripamil development
Milestone Pharmaceuticals said that it has raised $25 million from RTW Investments in a private placement and indicated that the proceeds would be sufficient for company operations through the second quarter of 2022. The company also announced that it had reached an agreement with the FDA regarding modifications to the design of a pivotal trial of its etripamil nasal … [Read more...] about Milestone Pharmaceuticals raises $25 million, provides update on etripamil development
VistaGen announces details of proposed Phase 3 trial of PH94B nasal spray for anxiety
VistaGen Therapeutics said that the FDA has agreed to details of a proposed Phase 3 trial of the company's PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track designation for that indication in December 2019. According to VistaGen, the Phase 3 trial will include "a single-event, laboratory-simulated public … [Read more...] about VistaGen announces details of proposed Phase 3 trial of PH94B nasal spray for anxiety
Synairgen’s inhaled interferon-beta-1a demonstrates significant benefit in hospitalized COVID-19 patients
Synairgen has announced that a Phase 2 clinical trial of its SNG001 nebulized interferon-beta-1a demonstrated that hospitalized COVID-19 patients receiving the drug were two times more likely to recover over the course of treatment; had significantly less dyspnea; and had a 79% lower risk of requiring ventilation and/or dying than patients receiving a a placebo. … [Read more...] about Synairgen’s inhaled interferon-beta-1a demonstrates significant benefit in hospitalized COVID-19 patients
Atossa to advance AT-301 nasal spray into clinical development for COVID-19
Atossa Therapeutics said that preclinical testing of its AT-301 nasal spray in VERO cells has demonstrated that it can limit SARS-CoV-2 infectivity, and the company has contracted with Australian CRO Advance Clinical for a Phase 1 trial, which is expected to begin this quarter. The company also said that it has filed provisional patent applications in the US to cover … [Read more...] about Atossa to advance AT-301 nasal spray into clinical development for COVID-19
Ferring issues recall of desmopressin nasal sprays
According to the UK's Medicines & Healthcare products Regulatory Agency (MHRA), Ferring Pharmaceuticals has recalled multiple batches of Desmospray 0.1 mg/ml desmopressin, Aspire branded desmopressin 0.1 mg/ml, and Octim desmopressin 1.5 mg/ml nasal sprays "due to a lower volume of solution being observed in the bottles, and out of specification results for the … [Read more...] about Ferring issues recall of desmopressin nasal sprays
Preclinical studies of Altimmune’s AdCOVID intranasal vaccine candidate demonstrate strong immune response in mice
Altimmune has announced that a study of its AdCOVID intranasal vaccine candidate induced a strong immune response in a mouse model. The results support advancing AdCOVID into a Phase 1 development, the company said, and it plans to begin manufacturing the vaccine for a trial in the fourth quarter of this year. The company recently said that it has partnered with … [Read more...] about Preclinical studies of Altimmune’s AdCOVID intranasal vaccine candidate demonstrate strong immune response in mice
CEBINA says azelastine nasal spray has potential for COVID-19
Vienna-based biotech incubator CEBINA (Central European Biotech Incubator and Accelerator) said that in vitro testing has shown that azelastine has anti-SARS-CoV-2 activity, and the company is discussing possible development and production of an azelastine nasal spray for the treatment of COVID-19 with Sigmapharm. CEBINA added that it has also filed a patent … [Read more...] about CEBINA says azelastine nasal spray has potential for COVID-19
PureIMS initiates Phase 1 trial of amikacin DPI for tuberculosis
Dutch inhaled drug developer PureIMS said that it has initiated a Phase 1 clinical trial of its Amikacin Cyclops DPI, which it is developing for the treatment of drug susceptible tuberculosis. The single ascending dose study is expected to enroll eight tuberculosis patients, with results anticipated later this year. The dry powder amikacin formulation is … [Read more...] about PureIMS initiates Phase 1 trial of amikacin DPI for tuberculosis