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
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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
Phase 1b challenge study of Revelation’s REVTx-99b nasal spray fails to meet efficacy endpoints
Revelation Biosciences announced that the Phase 1b CLEAR challenge study of its REVTx-99b intranasal phosphorylated hexaacylated disaccharide (PHAD) in participants with allergies to rye grass pollen showed that the nasal drops were safe and well tolerated but failed to demonstrate any reduction of allergy symptoms or improvement in breathing. The company said that, … [Read more...] about Phase 1b challenge study of Revelation’s REVTx-99b nasal spray fails to meet efficacy endpoints
ARS to merge with Silverback to support development and commercialization of Neffy epinephrine nasal spray
ARS Pharmaceuticals plans to merge with Silverback Therapeutics, the companies said, with the combined company focused on approval and launch of ARS's Neffy (ARS-1) epinephrine nasal spray for the treatment of allergic reactions. Shareholders of Silverback, whose pipeline consists of a therapy for the treatment of chronic hepatitis B in early development, will own a … [Read more...] about ARS to merge with Silverback to support development and commercialization of Neffy epinephrine nasal spray
Phase 3 trial of VistaGen’s PH94B nasal spray for social anxiety disorder fails to meet primary endpoint
VistaGen Therapeutics said that the PALISADE-1 Phase 3 clinical trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder failed to meet its primary endpoint. The company announced the initiation of the PALISADE-1 trial in May 2021, and a second Phase 3 trial, PALISADE-2, got underway in September 2021. According to VistaGen, "the … [Read more...] about Phase 3 trial of VistaGen’s PH94B nasal spray for social anxiety disorder fails to meet primary endpoint