DPI developer Iconovo has announced that a PK study of its ICOres reservoir-based inhaler demonstrated that the device delivered a budesonide/formoterol dry powder formulation as expected compared to Symbicort Turbuhaler. According to the company, the clinical study, which enrolled 29 healthy volunteers, showed "slightly higher values for ICOres" related to … [Read more...] about Iconovo announces positive results for ICOres study
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AZTherapies appoints Jay Mohr as COO, Chief Business Officer, and Head of Commercial Development
AZTherapies, which is developing an inhaled cromolyn sodium/ibuprofen formulation, has named Jay Mohr as Chief Operating Officer, Chief Business Officer, and Head of Commercial Development. Mohr was most recently co-founder and Managing Director of Locust Walk Partners. According to his LinkedIn page, Mohr has some experience with OINDPs, beginning at … [Read more...] about AZTherapies appoints Jay Mohr as COO, Chief Business Officer, and Head of Commercial Development
Pulmatrix initiates Phase 2 trial of Pulmazole for ABPA in patients with asthma
Pulmatrix has announced the initiation of a Phase 2 clinical trial of Pulmazole inhaled itraconazole (PUR1900) for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma, with top line data expected in mid 2020. Cip Tech acquired rights to Pulmazole for this indication earlier this year, in a deal conditioned on Pulmatrix's ability to … [Read more...] about Pulmatrix initiates Phase 2 trial of Pulmazole for ABPA in patients with asthma
FDA accepts Insys NDA for naloxone nasal spray
Insys Therapeutics, which recently filed for bankruptcy, said that the FDA has accepted its NDA for the company's single unit dose naloxone nasal spray. In December 2018, Insys said that it planned to submit NDAs for both the naloxone nasal spray and an epinephrine nasal spray in 2019. Insys Chief Scientific Officer Venkat Goskonda said, “The FDA’s acceptance of … [Read more...] about FDA accepts Insys NDA for naloxone nasal spray
Seurat Therapeutics to use Kurve Technology device for intranasal migraine therapy
Kurve Technology has announced that Seurat Therapeutics will use Kurve's intranasal delivery technology for Seurat's IGF-1 nasal aerosol for the treatment and prevention of migraines. Details of the development and collaboration agreement were not disclosed. In October 2018, Seurat announced that it had received a ~$510,000 grant from the National Institute of … [Read more...] about Seurat Therapeutics to use Kurve Technology device for intranasal migraine therapy
Liquidia to develop additional inhaled drugs
Liquidia Technologies has announced amendments to its 2012 collaboration agreement with GlaxoSmithKline that gave GSK the rights to develop inhaled dry powder formulations based on Liquidia's PRINT particle manufacturing technology. Under the terms of the amended agreement, Liquidia gets development and commercialization rights to three PRINT-based inhalation … [Read more...] about Liquidia to develop additional inhaled drugs
Insmed raises additional $25.6 million in public offering
Insmed has announced that it raised ~$25.6 million in net proceeds through the sale of additional shares after a public offering earlier this year netted approximately $235.5 million. The underwriters of that offering had a 30-day option to purchase up to 1,042,307 additional shares of common stock from the company and up to 400,000 shares of common stock from … [Read more...] about Insmed raises additional $25.6 million in public offering
Glenmark gets CRL for Ryaltris, acquires Brazilian rights to Breezhaler DPIs
Glenmark Pharmaceuticals has revealed that the FDA issued a complete response letter to the company's NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray. The agency accepted the NDA for Ryaltris in August 2018 with a PDUFA date of March 21, 2019. According to Glenmark, the CRL references issues related to the drug master file for one of the … [Read more...] about Glenmark gets CRL for Ryaltris, acquires Brazilian rights to Breezhaler DPIs
Syqe launches cannabis inhaler in Israel
According to Syqe Medical, the company has received regulatory approval from the Israeli Ministry of Health to launch its metered-dose cannabis inhaler in Israel for the treatment of pain. The inhaler, which was previously available only for hospital use, will now be available to licensed patients. In 2016, the company announced that Teva would distribute the … [Read more...] about Syqe launches cannabis inhaler in Israel
Bevespi Aerosphere gets Japanese approval
The Japanese Ministry of Health, Labour and Welfare has approved AstraZeneca's Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. Bevespi Aerosphere has been approved for the treatment of COPD in the US since 2016 and in the EU since December 2018. Canada and Australia have also approved the inhaler, which is … [Read more...] about Bevespi Aerosphere gets Japanese approval