The FDA has approved low, medium, and high dose versions of Teva's AirDuo Digihaler fluticasone propionate/salmeterol digital DPI for the treatment of asthma, the company said. The inhaler should be available in the US sometime next year. AirDuo Respiclick has been approved by the FDA since January 2017 and was launched in the US in April of that year. The … [Read more...] about Teva’s AirDuo Digihaler approved by the FDA
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MannKind adds high potency DPI formulation manufacturing capacity
Inhaled drug developer MannKind Corporation announced that the company has expanded its capacity for commercial manufacturing of highly potent dry powder formulations at its facility in Danbury, Connecticut, USA. The new manufacturing suite includes bulk powder formulation and filling for high potency powders such as epinephrine, the company said. According to … [Read more...] about MannKind adds high potency DPI formulation manufacturing capacity
Iconovo announces positive results for ICOres study
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
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