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
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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
Medicon Valley Inhalation Symposium postponed
The Medicon Valley Inhalation Consortium (MVIC) has announced that the 2021 Medicon Valley Inhalation Symposium (MVIS), which was to take place on October 13-14 in Lund, Sweden, has been postponed indefinitely. The MVIC training session scheduled for October 11-12 in Lund will go ahead. MVIC called the postponement, "Very unfortunate, frustrating and even … [Read more...] about Medicon Valley Inhalation Symposium postponed
Vivera gets US patents for Zicoh smart inhaler
Within one week in August, Vivera Pharmaceuticals has announced the issuance of two US patents covering its Zicoh smart inhaler technology. The first is US Patent No. 11,083,850 ("Secure smart dosing system with automated delivery, measurement, and management") and the second is US Patent No. 11,090,449 ("Smart inhaler device with automated dose delivery, measurement, … [Read more...] about Vivera gets US patents for Zicoh smart inhaler
Aerami’s inhaled imatinib for PAH gets orphan drug designation
The FDA has granted orphan drug designation to Aerami Therapeutics's AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH), the company said. Aerami initiated a Phase 1 trial of AER– 901 in June 2021, with results expected by the end of the year. In June 2020, Aerami announced a partnership with inhalation CDMO Vectura for … [Read more...] about Aerami’s inhaled imatinib for PAH gets orphan drug designation