TFF Pharmaceuticals says that it will prioritize development of TFF TAC inhaled dry powder tacrolimus for the prevention of lung transplant rejection after receiving positive data from an ongoing Phase 2 trial. The company will now de-prioritize development of TFF VORI inhaled dry powder voriconazole for the treatment of invasive pulmonary aspergillosis. According … [Read more...] about TFF says it will prioritize development of its tacrolimus DPI
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Inhalon publishes data from preclinical studies of its inhaled muco-trapping therapies in RSV and SARS-CoV-2 models
Inhalon Biopharma has announced the publication of two articles that present data from preclinical studies of the company's inhaled "muco-trapping" technologies. The first, published in the journal Advanced Science, describes a study of nebulized delivery of Inhalon's Mota-MT antibody to the lungs of nonatal lambs infected with RSV. The second article, published … [Read more...] about Inhalon publishes data from preclinical studies of its inhaled muco-trapping therapies in RSV and SARS-CoV-2 models
AstraZeneca initiates 2 Phase 3 trials investigating the effects of Breztri Aerosphere MDI on cardiopulmonary factors and outcomes in COPD patients
AstraZeneca today announced the initiation of the Phase 3 ATHLOS and THARROS trials evaluating the effects of Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI on cardiopulmonary parameters and outcomes (including death) in COPD patients. Breztri was approved by the FDA for the treatment of COPD in July 2020. In August 2023, the agency issued a … [Read more...] about AstraZeneca initiates 2 Phase 3 trials investigating the effects of Breztri Aerosphere MDI on cardiopulmonary factors and outcomes in COPD patients
MannKind presents data from Phase 4 trial of Afrezza inhaled insulin
MannKind Corporation announced that it recently presented initial data from a meal challenge that was part of the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics. Afrezza was approved by the FDA for the treatment of Type 1 and Type 2 diabetes in adults in 2014. The company said that it will … [Read more...] about MannKind presents data from Phase 4 trial of Afrezza inhaled insulin
Vast announces appointments in preparation for clinical development of ALX1 inhalation solution
Vast Therapeutics has announced the appointments of former Aradigm Senior Medical Director Paul Bruinenberg as Chief Medical Officer and Chris Polage as Medical Director in preparation for clinical development of its ALX1 inhalation solution. Bruinenberg was most recently Senior Medical Officer of the TB Alliance. In addition to his stint at Aradigm, Bruinenberg's … [Read more...] about Vast announces appointments in preparation for clinical development of ALX1 inhalation solution
UWA researchers get A$500,000 grant for development of Spritz-OM probiotic nasal spray for ear infections
Researchers at the University of Western Australia have received a A$500,000 grant from the CUREator biotech incubator for development of the Spritz-OM probiotic nasal spray for the prevention of ear infections in children. The grant was one of 5 awarded recently as part of an effort to fund projects aimed at minimizing antimicrobial resistance. According to the … [Read more...] about UWA researchers get A$500,000 grant for development of Spritz-OM probiotic nasal spray for ear infections
ARS Pharmaceuticals says Phase 2 trial of Neffy epinephrine nasal spray for urticaria met primary endpoints
ARS Pharmaceuticals announced that a Phase 2 trial of Neffy epinephrine nasal spray in patients with chronic spontaneous urticaria demonstrated that 1 mg and 2 mg doses of the intranasal epinephrine both produced statistically significant and clinically meaningful improvement in symptoms such as hives and itchy skin as soon as 5 minutes post dose. The inpatient study … [Read more...] about ARS Pharmaceuticals says Phase 2 trial of Neffy epinephrine nasal spray for urticaria met primary endpoints
ReCode Therapeutics initiates Phase 1 trial of RCT2100 inhaled mRNA therapy for CF
ReCode Therapeutics has announced the initiation of a Phase 1 safety and tolerability study of RCT2100 inhaled CFTR mRNA-based therapy, which the company is developing for cystic fibrosis patients who do not benefit from CFTR modulators. The study is expected to enroll 32 healthy adults and will evaluate a single dose of nebulized RCT2100 against placebo. According … [Read more...] about ReCode Therapeutics initiates Phase 1 trial of RCT2100 inhaled mRNA therapy for CF
ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response supported by data from a repeat dose study with nasal allergen challenge as requested by the FDA. According to ARS, topline results from the study, which … [Read more...] about ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
LTR Pharma initiates BE study of Spontan vardenafil nasal spray
LTR Pharma has announced the initiation of a bioequivalence study of its Spontan vardenafil nasal spray, which the company is developing for the treatment of erectile dysfunction. According to LTR, the study will compare a single dose of Spontan, 5 mg (2 sprays of 2.5 mg each) to 10 mg tablets of vardenafil in healthy adult males. The company says that it intends to … [Read more...] about LTR Pharma initiates BE study of Spontan vardenafil nasal spray