Nocion Therapeutics has announced the initiation of the Phase 2b ASPIRE clinical trial of its NOC-110 inhaled dry powder taplucainium (formerly NTX-1175) in patients with chronic cough. Earlier this year, the company said that it had raised $62 million to conduct the trial, which is expected to enroll approximately 325 patients and will evaluate two dose levels of … [Read more...] about Nocion initiates Phase 2b trial of NOC-110 taplucainium DPI for the treatment of chronic cough
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NurExone’s ExoPTEN intranasal exosome therapy for spinal cord injuries get orphan designation from the EMA
NurExone Biologic announced that the EMA has granted orphan medicinal product designation to NurExone's ExoPTEN intranasal exosome therapy, which the company is developing for the treatment of spinal cord injury. In 2023, the FDA granted orphan drug designation to ExoPTEN, and the company held a pre-IND meeting with the agency in anticipation of beginning clinical … [Read more...] about NurExone’s ExoPTEN intranasal exosome therapy for spinal cord injuries get orphan designation from the EMA
AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
UK-based start-up AlveoGene announced that its AVG-002 nebulized gene therapy for neonatal surfactant protein B (SP-B) deficiency has received a rare pediatric disease designation from the FDA. The company says that it will advance AVG-002 into clinical development and could submit a marketing application as soon as 2028. According to Alveogene, studies in SP-B … [Read more...] about AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
Pulmatrix agrees to merge with Cullgen and will divest inhalation assets
Pulmatrix has announced a planned merger with biopharma Cullgen, which is developing oral protein degraders for the treatment of various indications. In anticipation of the merger, Pulmatrix says that it will divest inhalation assets, including PUR1800 inhaled dry powder narrow spectrum kinase inhibitor, PUR3100 inhaled dry powder DHE, and patents related to the … [Read more...] about Pulmatrix agrees to merge with Cullgen and will divest inhalation assets
ALK acquires rights to ARS’s neffy adrenaline (epinephrine) nasal spray in much of the world
Danish pharma company ALK says that it is paying ARS Pharmaceuticals $145 million up front and up to $320 million in potential milestone payments plus royalties for the rights to neffy intranasal adrenaline (epinephrine) everywhere except the US, Australia, New Zealand, Japan, and China. In addition to the marketing rights to neffy for the treatment of anaphylaxis, … [Read more...] about ALK acquires rights to ARS’s neffy adrenaline (epinephrine) nasal spray in much of the world
CHI partners with Aptar Pharma for commercialization of the Quattrii DPI platform
Aptar Pharma will commercialize and promote Cambridge Healthcare Innovations' Quattrii blister-based dry powder inhaler platform, the companies said. According to the announcement, the platform is tunable and can be used with carrier or API-only formulations. CHI's web site says that the Quattrii DPI can be filled with up to 150 mg of powder and is capable of … [Read more...] about CHI partners with Aptar Pharma for commercialization of the Quattrii DPI platform
Bespak announces closure of its North Carolina facilities
Inhalation CDMO Bespak recently announced that it will close its site in Research Triangle Park, NC, USA by the end of the first quarter of 2025. Bespak spun out from Recipharm earlier this year with the stated purpose of focusing on the transition of MDIs to LGWP propellants. According to the company's announcement, it will be moving "selected product … [Read more...] about Bespak announces closure of its North Carolina facilities
OzUK announces new GLP pilot plant for development of MDIs with LGWP propellants
CRO OzUK has announced the availability of a new GLP pilot plant designed for pilot and feasibility studies of both solution and suspension MDIs filled with low global warming potential (LGWP) propellants. OzUK announced plans for the new facility in December 2023. According to the company, the new facility meets ATEX (Atmosphères Explosibles) standards for safety, … [Read more...] about OzUK announces new GLP pilot plant for development of MDIs with LGWP propellants
Tiziana says study of intranasal foralumab in addition to semaglutide demonstrated synergistic effects in mouse model of obesity
Tiziana Life Sciences announced that a preclinical study of its intranasal foralumab in combination with semaglutide (Ozempic / Wegovy) demonstrated synergistic effects in a mouse model of obesity, improving liver function and reducing inflammation more than semaglutide alone. The company says that it plans "to advance these promising preclinical findings into … [Read more...] about Tiziana says study of intranasal foralumab in addition to semaglutide demonstrated synergistic effects in mouse model of obesity
MannKind announces that results of Phase 1 trial of MNKD-201 nintedanib DPI support continued development
MannKind Corporation has announced that data from a recently completed Phase 1 study of MNKD-201 nintedanib DPI support continued development of the inhaler for the treatment of idiopathic pulmonary fibrosis (IPF). MannKind had announced plans for the Phase 1 SAD/MAD study earlier this year. The announcement includes highlights of safety results and does not present … [Read more...] about MannKind announces that results of Phase 1 trial of MNKD-201 nintedanib DPI support continued development