The annual Drug Delivery to the Lungs (DDL) conference will mark its 35th anniversary during this … [Read More...] about DDL 2024 to celebrate 35 years as a leading OINDP conference
DDL 2024 to celebrate 35 years as a leading OINDP conference
A Q&A with Copley’s Clair Brooks on alternative BE approaches in new FDA guidance
A striking feature of recent batches of OINDP product specific guidances (PSGs) is the inclusion of … [Read More...] about A Q&A with Copley’s Clair Brooks on alternative BE approaches in new FDA guidance
Human Factors (HF) Considerations for Generic Inhalers Using Off-the-shelf Devices
By Yvonne Limpens, Managing Human Factors Specialist at Emergo by UL While the time to market … [Read More...] about Human Factors (HF) Considerations for Generic Inhalers Using Off-the-shelf Devices
Latest news
Nocion initiates Phase 2b trial of NOC-110 taplucainium DPI for the treatment of chronic cough
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 … [Read More...] about Nocion initiates Phase 2b trial of NOC-110 taplucainium DPI for the treatment of chronic cough
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 … [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 … [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 … [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 … [Read More...] about ALK acquires rights to ARS’s neffy adrenaline (epinephrine) nasal spray in much of the world
Other recent news
- CHI partners with Aptar Pharma for commercialization of the Quattrii DPI platform
- Bespak announces closure of its North Carolina facilities
- 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
- MannKind announces that results of Phase 1 trial of MNKD-201 nintedanib DPI support continued development