According to Inhalation Sciences (ISAB), the FDA will provide up to $500,000 over two years to fund a study intended to validate ISAB's DissolvIt in vitro lung simulation model for dissolution testing of inhaled drugs. The company said that the agency's National Center for Toxicological Research has approved the research proposal, and the study is expected to begin … [Read more...] about FDA to provide funding for study to validate Inhalation Sciences’ DissolvIt lung simulation model for dissolution testing of inhaled drugs
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Adherium submits 510(k) application for a Hailie sensor for use with Ventolin, Advair, and Flovent MDIs
Just over a week after receiving 510(k) clearance for a Hailie inhaler sensor for use with Ellipta DPIs, Adherium said that it filed a 510(k) submission to the FDA for a new Hailie sensor to be used with GSK's Ventolin, Advair, and Flovent MDIs. The new Hailie sensor measures various parameters, including respiratory flow rate, and connects to the company's Hailie … [Read more...] about Adherium submits 510(k) application for a Hailie sensor for use with Ventolin, Advair, and Flovent MDIs
Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients
Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans in bilateral lung transplant patients who have recently had a reduction in lung function. ARINA-1, which is delivered via the PARI eFlow nebulizer … [Read more...] about Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients
Tonix gets US patent for the use of intranasal potentiated oxytocin for the treatment of migraine
According to Tonix Pharmaceuticals, the United States Patent and Trademark Office has issued the company US Patent 11,389,473,"Magnesium-Containing Oxytocin Formulations and Methods of Use," which includes claims related to the use of such formulations for the treatment of pain such as migraine headache. The anticipated expiration date for the patent is January 7, … [Read more...] about Tonix gets US patent for the use of intranasal potentiated oxytocin for the treatment of migraine
Krystal Biotech announces Phase 1 trial of KB407 inhaled gene therapy for cystic fibrosis
Krystal Biotech said that the FDA has cleared an IND submitted by the company at the beginning of July 2022 and that it now intends to initiate a Phase 1 trial of its KB407 nebulized re-dosable gene therapy for the treatment of cystic fibrosis sometime before the end of this year. The company had previously announced a Phase 1 study of KB407 taking place in Australia. … [Read more...] about Krystal Biotech announces Phase 1 trial of KB407 inhaled gene therapy for cystic fibrosis
Atossa to refocus development of AT-H201 on the treatment of radiation-induced lung injury
Atossa Therapeutics said that it has completed the first three parts of a Phase 1/2a trial, which was announced in July 2021, but it will skip the remaining part. Part D had been expected to enroll hospitalized COVID-19 patients; however, the company said that it will instead shift development of the inhaled heparin / n-acetylcysteine therapy to the treatment of … [Read more...] about Atossa to refocus development of AT-H201 on the treatment of radiation-induced lung injury
ACM Biolabs initiates Phase 1 trial of ACM-001 intranasal COVID-19 vaccine
ACM Biolabs has announced the initiation of a Phase 1 trial of its ACM-001 vaccine candidate against SARS-CoV-2. The SAD study will compare ACM-001 to an intramuscular vaccine as a booster in 80 healthy adults who have already received 3 doses of a COVID-19 vaccine. According to ACM, the intranasal vaccine is based on the company's artificial cell membrane (ACM) … [Read more...] about ACM Biolabs initiates Phase 1 trial of ACM-001 intranasal COVID-19 vaccine
Iconovo gets grant from Gates Foundation for development of nasal DPI
DPI developer Iconovo announced that it has received a $883,800 grant from the Bill & Melinda Gates Foundation for development of a nasal inhaler based on the company's ICOone single dose device. In March 2021, Iconovo announced that it was developing a nasal version of the ICOone inhaler for use with an ISR COVID-19 vaccine and later said that it had received an … [Read more...] about Iconovo gets grant from Gates Foundation for development of nasal DPI
InCarda Therapeutics initiates Phase 3 trial of InRhythm inhaled flecainide for atrial fibrillation
InCarda Therapeutics has announced the initiation of the Phase 3 RESTORE-1 trial of its InRhythm flecainide inhalation solution in patients with new or recurrent atrial fibrillation. According to InCarda, the FDA has agreed that the RESTORE-1 trial alone will be sufficient to support an NDA for the flecainide inhalation solution for use under medical supervision to … [Read more...] about InCarda Therapeutics initiates Phase 3 trial of InRhythm inhaled flecainide for atrial fibrillation
Adherium announces 510(k) clearance for Hailie sensor for use with Ellipta DPIs and new distribution deal
Hailie inhaler monitoring system maker Adherium announced that the FDA has cleared the company's new version of the Hailie sensor for use with Ellipta dry powder inhalers. Adherium submitted the 510(k) application to the FDA in March 2022. The company said that the new clearance means that Hailie is now eligible for reimbursement on 18 of the top 20 branded inhalers … [Read more...] about Adherium announces 510(k) clearance for Hailie sensor for use with Ellipta DPIs and new distribution deal