Zambon has announced that the Phase 3 BOSTON-1 and BOSTON-2 trials of liposomal cyclosporine A for inhalation (L-CsA-i) have completed enrollment. The two trials were initiated by Breath Therapeutics in March 2019 prior to that company's acquisition by Zambon. Breath Therapeutics was spun off from PARI Pharma in 2017 to develop L‑CsA‑i, which has received Fast Track … [Read more...] about Zambon announces completion of enrollment in Phase 3 studies of inhaled liposomal cyclosporine A for the treatment of BOS
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Copley Scientific launches Impactor Genie IG 200i
Copley Scientific has announced the launch of the Impactor Genie IG 200i semi-automated tool for impaction surface coating and drug dissolution that can be used with either Andersen cascade impactors or Next Generation Impactors. According to Copley, the Impactor Genie IG 200i combines the functions of the new Impactor Coater IC 200i, which can coat collection cups … [Read more...] about Copley Scientific launches Impactor Genie IG 200i
Arrowhead reports interim data from Phase 1/2a trial of ARO-RAGE inhaled RNAi for lung diseases
Arrowhead Pharmaceuticals said that interim data from the ARORAGE-1001 Phase 1/2a trial of its ARO-RAGE inhaled RNAi therapeutic, which it is developing for the treatment of inflammatory lung diseases, demonstrate reductions in soluble receptor for advanced glycation end products (RAGE) as high as 90% in healthy volunteers at the 4th highest dose with no indications … [Read more...] about Arrowhead reports interim data from Phase 1/2a trial of ARO-RAGE inhaled RNAi for lung diseases
Amphastar acquires Baqsimi intranasal dry powder glucagon from Lilly
Amphastar Pharmaceuticals will pay Eli Lilly $500 million up front, an additional $125 million after one year, and up to $450 million in sales milestone payments for the rights to Baqsimi intranasal dry powder glucagon. The company says that the product is currently marketed in 27 countries. Baqsimi was approved by the FDA in July 2019 for the emergency treatment of … [Read more...] about Amphastar acquires Baqsimi intranasal dry powder glucagon from Lilly
Ritedose begins manufacturing 0.5% albuterol sulfate inhalation solution ampules
Ritedose Corporation, which says that it is the largest manufacturer of albuterol sulfate inhalation solution in the US, announced that it has begun compounding 5 mg/ml albuterol sulfate inhalation solution ampules through the 503B manufacturing process in response to a shortage, with shipping directly to hospitals expected to begin in May of this year. The … [Read more...] about Ritedose begins manufacturing 0.5% albuterol sulfate inhalation solution ampules
Tiziana announces plans for development of intranasal foralumab for diabetes, Alzheimer’s
Tiziana Life Sciences has announced plans for development of its foralumab intranasal anti-CD3 monoclonal antibody for two additional indications, Type 1 diabetes and Alzheimer's disease. Tiziana said that it is initiating a development program for diabetes and that it plans to submit an IND for clinical development of foralumab in patients with Alzheimer's in the … [Read more...] about Tiziana announces plans for development of intranasal foralumab for diabetes, Alzheimer’s
Vyne announces preclinical data for inhaled VYN201 in mouse model of IPF
Vyne Therapeutics said that an inhaled formulation of its VYN201 pan-BET inhibitor significantly reduced lung fibrosis and hydroxyproline levels in a mouse model of idiopathic pulmonary fibrosis (IPF) at doses of 0.5 mg/ml and 1 mg/ml, and functional lung volume and blood oxygen saturation were significantly improved. A topical formulation of VYN201 is currently in … [Read more...] about Vyne announces preclinical data for inhaled VYN201 in mouse model of IPF
Leyden Labs initiates Phase 1 trial of PanFlu CR9114 nasal spray
Leyden Laboratories has initiated a Phase 1 trial of its intranasal PanFlu CR9114 anti-hemagglutinin stem human antibody in healthy volunteers, the company said. In July 2021, Leyden Labs announced that it had partnered with Nanopharm on development of intranasal formulations for Phase 1 studies. According to Leyden Labs, preclinical studies of CR9114 in animal models … [Read more...] about Leyden Labs initiates Phase 1 trial of PanFlu CR9114 nasal spray
Renovion initiates Phase 3 trial of ARINA-1 nebulized mucolytic in patients who have had a bilateral lung transplant
Renovion has initiated a Phase 3 clinical study of its ARINA-1 inhaled glutathione / bicarbonate / ascorbic acid for the treatment of bronchiolitis obliterans syndrome (BOS) following bilateral lung transplant. ARINA-1 recently received Fast Track designation for that indication. Plans for the Phase 3 trial were announced in August 2022. According to the company, the … [Read more...] about Renovion initiates Phase 3 trial of ARINA-1 nebulized mucolytic in patients who have had a bilateral lung transplant
ReCode Therapeutics hires John G. Matthews as Senior VP of Clinical Development
ReCode Therapeutics, which is developing inhaled mRNA therapeutics for the treatment of primary ciliary dyskinesia and cystic fibrosis, has named John G. Matthews as Senior VP of Clinical Development. ReCode initiated a Phase 1 trial of its RCT1100 nebulized DNAI1 mRNA in March 2023. A pulmonologist, Matthews has extensive experience in respiratory disease research … [Read more...] about ReCode Therapeutics hires John G. Matthews as Senior VP of Clinical Development