Kinaset Therapeutics said that dosing is underway in a Phase 1b SAD/MAD study of its KN-002 dry powder JAK inhibitor, which it is developing for the treatment of asthma and COPD. The trial is expected to enroll 48 healthy volunteers in the single ascending dose portion of the study and 32 asthma patients in the multiple ascending dose part of the study. The … [Read more...] about Kinaset initiates Phase 1b trial of its KN-002 dry powder JAK inhibitor
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Theravance Biopharma restructures, will focus on respiratory drugs
Theravance Biopharma said that it expects to cut 270 jobs, or 75% of its current workforce, by February 2022 and that it will stop development of candidates outside of its respiratory portfolio. The announcement came just after the company announced the failure of a Phase 3 trial of its oral ampreloxetine. The company said that its R&D focus will now be on a label … [Read more...] about Theravance Biopharma restructures, will focus on respiratory drugs
VistaGen initiates second Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder
VistaGen Therapeutics said that it has initiated the PALISADE-2 Phase 3 clinical trial of its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). The company initiated the PALISADE-1 trial of PH94B for SAD in May 2021. Topline results from that trial are expected in mid-2022, with results from the PALISADE-2 trial expected later that … [Read more...] about VistaGen initiates second Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder
Adherium’s next generation Hailie inhaler sensor gets 510(k) clearance
According to Adherium, the company has received 510(k) clearance from the FDA for its next generation Hailie inhaler sensor. The new version of the Hailie sensor, which is meant to be used with the Symbicort MDI, includes the ability to capture clinical data in addition to inhaler usage data. Adherium says that the additional capability for monitoring asthma and COPD … [Read more...] about Adherium’s next generation Hailie inhaler sensor gets 510(k) clearance
Positive results for two Phase 3 studies of AstraZeneca’s PT027 albuterol/budesonide MDI
AstraZeneca has announced that the Phase 3 MANDALA and DENALI trials of PT027 albuterol (salbutamol)/budesonide MDI for the treatment of asthma both met their primary endpoints. The company has been co-developing PT027 with Avillion since 2018. The MANDALA trial, which enrolled 3,132 patients who were using inhaled corticosteroids for moderate to severe asthma, … [Read more...] about Positive results for two Phase 3 studies of AstraZeneca’s PT027 albuterol/budesonide MDI
POC study demonstrates feasibility of using Nanoform’s nanoforming technology for potential intranasal formulation of CDNF
Nanoform Finland and Herantis Pharma say that they have successfully demonstrated the feasibility of using Nanoform's nanoparticle technology for a potential intranasal formulation of Herantis's cerebral dopamine neurotrophic factor (CDNF) for the treatment of Parkinson's disease, with the protein remaining stable and active following processing. The two companies … [Read more...] about POC study demonstrates feasibility of using Nanoform’s nanoforming technology for potential intranasal formulation of CDNF
Phase 3 trial of nebulized colistimethate sodium in patients with bronchiectasis and P. aeruginosa infection meets primary endpoint
Zambon has presented results from its Phase 3 PROMIS-I study of CMS colistimethate sodium powder demonstrating that a CMS solution delivered via the Philips I-neb nebulizer significantly reduced exacerbations in patients with non-cystic fibrosis bronchiectasis (NCFB) and chronic P. aeruginosa lung infections. The company received Fast Track and QIDP designations for … [Read more...] about Phase 3 trial of nebulized colistimethate sodium in patients with bronchiectasis and P. aeruginosa infection meets primary endpoint
FDA approves Trudhesa DHE nasal spray for the treatment of migraine
According to Impel NeuroPharma, the FDA has approved the company's Trudhesa dihydroergotamine mesylate nasal spray for the treatment of migraine. Impel submitted the NDA for Trudhesa (INP104) in November 2020, and the agency accepted the application in January 2021. The company said that it plans to launch Trudhesa in the US in early October 2021 and that it will … [Read more...] about FDA approves Trudhesa DHE nasal spray for the treatment of migraine
Nocion Therapeutics announces Phase 2a trial of inhaled NTX-1175 charged sodium channel blocker for chronic cough
Nocion Therapeutics has dosed the first 10 subjects in a Phase 2a study of NOC-100, an inhaled formulation of its NTX-1175, a charged sodium channel blocker, the company said. Nocion is developing NTX-1175 for the treatment of chronic and acute cough, including cough resulting from COVID-19. According to the company, a Phase 1 study of inhaled NTX-1175 was completed … [Read more...] about Nocion Therapeutics announces Phase 2a trial of inhaled NTX-1175 charged sodium channel blocker for chronic cough
ARS raises $55 million for potential launch of its Neffy intranasal epinephrine
ARS Pharmaceuticals said that it has raised $55 million in a Series D financing round to support approval and potential launch of its Neffy (ARS-1) intranasal epinephrine for the treatment of anaphylaxis as well as studies of the nasal spray for other indications. ARS submitted an MAA for Neffy to the EMA in November 2020. The FDA granted Fast Track designation … [Read more...] about ARS raises $55 million for potential launch of its Neffy intranasal epinephrine