Satsuma Pharmaceuticals has initiated the SUMMIT Phase 3 trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine, the company said. A previous Phase 3 trial of STS101 called EMERGE failed to meet its primary endpoints. Topline data from the SUMMIT trial are expected in the second half of 2022. The SUMMIT trial is expected to enroll … [Read more...] about Satsuma initiates new Phase 3 trial of STS101 intranasal DHE powder for migraine
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In vitro tests show Augmenta/TFF dry powder mAb neutralizes SARS-C0V-2 Delta variant
Augmenta Bioworks and TFF Pharmaceuticals have announced that in vitro testing of their AUG-3387 dry powder monoclonal antibody has demonstrated that the mAb neutralizes the SARS-CoV-2 Delta variant, the highly transmissible strain that is currently dominant in numerous countries. In vitro tests had already demonstrated that the mAb could be effective against other … [Read more...] about In vitro tests show Augmenta/TFF dry powder mAb neutralizes SARS-C0V-2 Delta variant
Lannett to market Respirent’s generic of Spiriva Handihaler in the US
According to Lannett, the company has acquired US rights to market Respirents generic of Spiriva Handihaler tiotropium bromide DPI for a 10-year period, the company said. Lannett had already acquired US rights to Respirent's generic versions of Advair Diskus in 2019 and Flovent Diskus in 2020. Lannett CEO Tim Crew commented, "We continue to add drug and device … [Read more...] about Lannett to market Respirent’s generic of Spiriva Handihaler in the US
Positive results for Phase 1 trial of CanSinoBio inhaled COVID-19 vaccine
Results from a Phase 1 trial of an inhaled version of CanSino Biologic's Ad5-nCoV vaccine against COVID-19 have been published online in The Lancet Infectious Diseases. The study enrolled 130 healthy volunteers who got either intramuscular Ad5-nCoV, two doses of aerosolized vaccine, or IM vaccine with an aerosolized booster and found that the nebulized vaccine was … [Read more...] about Positive results for Phase 1 trial of CanSinoBio inhaled COVID-19 vaccine
InnarisBio to develop sol-gel delivery technology for intranasal CNS drugs
Atai Life Sciences and University of Queensland technology transfer company UniQuest have announced the launch of a new company called InnarisBio, which will develop intranasal drug delivery technology for CNS drugs based on sol-gel technology developed by Queensland School of Pharmacy Senior Lecturer Harendra (Harry) Parekh. The sol-gel technology platform involves … [Read more...] about InnarisBio to develop sol-gel delivery technology for intranasal CNS drugs
Inhaled dry powder tamibarotene effective against respiratory viruses in preclinical studies
Preclinical studies by researchers from the LKS Faculty of Medicine at The University of Hong Kong have demonstrated that a dry powder formulation of tamibarotene delivered to the lungs of hamster and mice has broad activity against respiratory viruses, including SARS-CoV-2, MERS-CoV, and influenza A H1N1. Results from the studies were published in Advanced … [Read more...] about Inhaled dry powder tamibarotene effective against respiratory viruses in preclinical studies
H&T Presspart acquires Novelex
H&T Presspart has acquired Swiss device maker Novelex (formerly Forteq Nidau), the company said, and all Novelex employees will be absorbed into H&T Presspart. The company acquired Novelex from Liberta Partners, which had acquired Forteq Nidau in November 2020. Two partners from Liberta Partners, Florian Korp and Peter Franke, commented, "H&T … [Read more...] about H&T Presspart acquires Novelex
Sorrento initiates Phase 2 trial of its intranasal neutralizing antibody against COVID-19
Sorrento Therapeutics has initiated a Phase 2 trial of its CoviDrops intranasal neutralizing antibody in COVID-19 patients in the UK, the company said. The trial is expected to enroll 350 COVID-19 patients who have mild symptoms or are asymptomatic who will get either 10 mg or 20 mg of CoviDrops via nasal instillation or placebo. Treatment and assessment will take … [Read more...] about Sorrento initiates Phase 2 trial of its intranasal neutralizing antibody against COVID-19
Esteve Pharmaceuticals to market Inbrija levodopa DPI in Spain
Esteve Pharmaceuticals has acquired the exclusive rights to market Inbrija dry powder levodopa in Spain and expects to launch the product there by the end of 2022, according to Acorda Therapeutics. Esteve will pay Acorda "a significant double-digit percent of the selling price" for Acorda to supply the product. The Inbrija DPI was approved in Europe for the … [Read more...] about Esteve Pharmaceuticals to market Inbrija levodopa DPI in Spain
Celltrion, Inhalon partner on inhaled regdanvimab for COVID-19
Inhalon Biopharma has announced that it is partnered with Celltrion to develop a nebulized formulation of regdanvimab, a monoclonal antibody for the treatment of COVID-19, which will be known as IN-006. In May 2021, Inhalon announced that it had been awarded a US Army contract worth $7 million for development of IN-006. The company says that a Phase 1 study of IN-006 … [Read more...] about Celltrion, Inhalon partner on inhaled regdanvimab for COVID-19