Oramed Pharmaceuticals (Nasdaq:ORMP) announced that top-line Phase 3 trial results for its oral insulin candidate missed its endpoints. The Phase 3, randomized, double-blind, placebo-controlled trial compared the efficacy of ORMD-0801 to placebo. It evaluated patients with type 2 diabetes at 26 weeks. ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control. Those patients were […]
Pharmaceuticals
Vero Biotech raises $30M for tankless nitric oxide delivery system
Vero Biotech announced today that it raised $30 million to support its Genosyl inhaled nitric oxide (iNO) delivery system. The financing comes just days after the company received FDA approval for Genosyl. The third-generation Genosyl delivery system features faster dosing, simpler workflow and operational efficiency. Petrichor, a healthcare-dedicated growth capital provider, led the financing. Atlanta-based […]
FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech
Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide (iNO) delivery system. Atlanta-based Vero Biotech developed its third-generation Genosyl delivery system for respiratory therapists. Its new features include faster dosing, simpler workflow and operational efficiency. The system speeds up dosing with an adaptive sensor and automated cassette activation feature. […]
Sustained Therapeutics advances novel drug delivery platform
Sustained Therapeutics announced that it received regulatory approval in Canada to begin a Phase II trial of its novel pain medication. Vancouver, BC-based Sustained Therapeutics develops a long-lasting non-opioid pain medication. Its trial evaluates a sustained-release platform technology to aid in chronic pain treatment. The company said in a news release that it designed the […]
OraMed wins U.S. combination therapy patent for oral GLP-1, insulin
Oramed Pharmaceuticals (Nasdaq:ORMP) announced today that it received a new patent for its oral diabetes treatment. The U.S. Patent and Trademark Office (USPTO) granted a patent titled “Methods and Compositions for Treating Diabetes.” This patent extends a patent previously granted in May 2022. According to a news release, the patent addresses methods and compositions for […]
Interim data supports Vaxess shelf-stable flu vaccine patch
Vaxess Technologies today announced positive interim results from a first-in-human trial of its influenza vaccine patch. Cambridge, Massachusetts-based Vaxess evaluated VX-103, a monovalent seasonal influenza vaccine patch. The trial included 45 healthy patients and evaluated the H1N1 influenza antigen from Vaxess’ partner, GC Biopharma. Delivery of the vaccine took place through the Vaxess Mimix patch. […]
FDA accepts NDA for over-the-counter Narcan nasal spray from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) recently announced that the FDA accepted for review its over-the-counter Narcan (naloxone HCI) nasal spray. The FDA last week accepted Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment. It also granted the application priority review. If approved, it would represent the first 4 mg naloxone nasal spray […]
FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals
ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription […]
Vaxxas raises $23M for needle-free drug delivery tech
Vaxxas announced today that it completed a financing round that brings in $23 million (A$34 million) in new funds. Existing investors OneVentures and UniQuest led the round. New investors, including members of the Vaxxas board and management team, along with individual investors, participated. The company earmarked proceeds to advance its clinical programs, including its needle-free […]
BD opens $38.6M medication management manufacturing plant in Mexico
BD (NYSE:BDX) announced recently that it inaugurated a new $38.6 million manufacturing facility in Tijuana, Mexico. Government officials from Mexico and the state of Baja California joined in the opening of the medication management plant. BD plans for the facility to produce devices and technologies that improve medication safety within healthcare settings. According to a […]