According to Kenox Pharmaceuticals, the company "received a positive response supporting the planned CMC, non-clinical and clinical development strategy" following a pre-IND meeting with FDA regarding the company's KNX018 inhaled sensitizer for use with radiation therapy for the treatment of non-small cell lung cancer (NSCLC). The company said that it now plans to … [Read more...] about Kenox says it has completed pre-IND meeting with FDA regarding its inhaled sensitizer for lung cancer radiation therapy
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IDRI gets BARDA contract for intranasal RNA flu vaccine
US-based non-profit biotech Infectious Disease Research Institute (IDRI) said that it has received a 2-year contract from the Biomedical Advanced Research and Development Authority (BARDA) for development of an intranasal RNA vaccine against influenza as part of BARDA's "Beyond the Needle" initiative. The initial vaccine will be targeted against H5N1 flu. IDRI … [Read more...] about IDRI gets BARDA contract for intranasal RNA flu vaccine
Aerogen to supply nebulizers for delivery of CanSinoBio’s Convidecia inhaled COVID-19 vaccine
Nebulizer maker Aerogen and CanSino Biologics have signed a development and commercial supply deal for the use of Aerogen's vibrating mesh nebulizer technology for delivery of CanSinoBIO’s Convidecia inhaled vaccine against COVID-19. Terms of the deal were not disclosed. Earlier this year, CanSinoBio announced positive results from a Phase 1 trial of the Ad5-nCoV … [Read more...] about Aerogen to supply nebulizers for delivery of CanSinoBio’s Convidecia inhaled COVID-19 vaccine
Nanopharm announces expansion
OINDP contract research and development company Nanopharm, a subsidiary of Aptar Pharma, has announced plans to move to a 25,000 sq ft building in Cwmbran, Wales that will house brand new R&D space and cGMP analytical labs. The new facility will be 4 times larger than the company's existing location and will allow Nanopharm to increase its capacity to the extent … [Read more...] about Nanopharm announces expansion
McMaster University announces Phase 1 trial of two inhaled COVID-19 vaccines
McMaster University announced that Health Canada has cleared a Phase 1 trial of two inhaled adenovirus vector vaccines against SARS-CoV-2, and the study is set to begin shortly. The trial is expected to enroll at least 30 healthy volunteers who have already received two doses of an mRNA vaccine. Each of the participants will receive a single dose of one of the … [Read more...] about McMaster University announces Phase 1 trial of two inhaled COVID-19 vaccines
Aerami Therapeutics to go public through SPAC merger
Inhaled drug developer Aerami Therapeutics has announced that it will go public through a merger with a special purpose acquisition company (SPAC) called FoxWayne Enterprises Acquisition Corp., and the resulting company’s common stock will be listed on the Nasdaq Capital Market. According to Aerami, the proceeds from the merger will be used for further development of … [Read more...] about Aerami Therapeutics to go public through SPAC merger
CF Foundation providing $3.5 million for development of Pulmocide’s inhaled opelconazole
The Cystic Fibrosis Foundation announced that it is providing $3.5 million for a Phase 2 study of Pulmocide Ltd's PC945 inhaled opelconazole for the prevention of pulmonary Aspergillus infections following lung transplantation. The CF Foundation noted that this is the organization's first investment in development of a drug specifically for treatment related to lung … [Read more...] about CF Foundation providing $3.5 million for development of Pulmocide’s inhaled opelconazole
Phase 3 trial of Biohaven’s intranasal zavegepant for migraine meets its primary endpoints
Biohaven Pharmaceutical said that a Phase 3 trial of its intranasal zavegepant (BHV-3500) for the treatment of moderate or severe migraine has met its primary endpoints, demonstrating statistically significant increase in freedom from both pain and most bothersome symptom compared to placebo. This is the second pivotal trial of intranasal zavegepant for migraine; in … [Read more...] about Phase 3 trial of Biohaven’s intranasal zavegepant for migraine meets its primary endpoints
Lupin acquires rights to TTP’s SMI technology
Lupin announced that it has acquired exclusive global rights to soft mist inhalation technology developed by Cambridge, UK design company TTP, and the two companies will co-develop the SMI device for delivery of inhaled drugs. Formulation development, regulatory submissions, commercial manufacturing, and commercialization of soft mist inhalers based on the TTP … [Read more...] about Lupin acquires rights to TTP’s SMI technology
Andrew Colin joins Beyond Air as Chief Medical Officer
Inhaled nitric oxide developer Beyond Air announced that pulmonologist Andrew Colin has been appointed as the company's Chief Medical Officer, effective December 1, 2021. Colin, who was most recently Chief of the Division of Pediatric Pulmonology at the University of Miami's Miller School of Medicine and Director of the university's Cystic Fibrosis Center, has … [Read more...] about Andrew Colin joins Beyond Air as Chief Medical Officer