Inhaled drug developer Savara has announced that the Phase 3 IMPALA study of Molgradex inhaled formulation recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) failed to meet its primary endpoint, improvement in alveolar-arterial oxygen gradient (A-aDO2). The study … [Read more...] about Phase 3 study of Molgradex inhaled GM-CSF for the treatment of aPAP fails to meet primary endpoint
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Dance Biopharm presents positive Phase 2 results for Dance 501 inhaled insulin
During the 2019 annual meeting of the American Diabetes Association (ADA), Dance Biopharm presented data from the Phase 2 Samba 04 clinical trial of Dance 501 inhaled insulin for the treatment of Type 2 diabetes demonstrating that Dance 501 had a more rapid onset of action than subcutaneous insulin lispro. The Samba 04 study enrolled 24 Type 2 patients who were … [Read more...] about Dance Biopharm presents positive Phase 2 results for Dance 501 inhaled insulin
Study demonstrates feasibility of inhaled lipid cisplatin delivery via Windtree’s ADS
Windtree Therapeutics and Eleison Pharmaceuticals have announced results from a study that demonstrated the feasibility of delivering Eleison's inhaled lipid cisplatin (ILC) via Windtree's Aerosol Delivery System (ADS). In March 2018, the companies announced that they had partnered for development of ILC for the treatment of lung cancer. According to the … [Read more...] about Study demonstrates feasibility of inhaled lipid cisplatin delivery via Windtree’s ADS
Verona Pharma initiates Phase 2 trial of RPL554 ensifentrine MDI
Verona Pharma has initiated a Phase 2 trial of the MDI formulation of RPL554 ensifentrine in COPD patients, the company said. Verona recently announced the initiation of a Phase 2b study of nebulized ensifentrine and interim results from a Phase 2 study of the DPI formulation for COPD. The Phase 2 study of the MDI formulation is expected to enroll 36 patients with … [Read more...] about Verona Pharma initiates Phase 2 trial of RPL554 ensifentrine MDI
Study shows ARS-1 intranasal epinephrine has similar PK profile to intramuscular epinephrine
ARS Pharmaceuticals has announced results from the EPI-04 clinical study demonstrating that the company's ARS-1 intranasal epinephrine spray has a pharmacokinetic profile that is similar to intramuscular epinephrine. ARS is developing ARS-1 for the treatment of anaphylaxis, and ARS-1 received Fast Track Designation for that indication earlier this year. The EPI-04 … [Read more...] about Study shows ARS-1 intranasal epinephrine has similar PK profile to intramuscular epinephrine
Phase 3 trial of QVM149 meets primary and secondary endpoints
Novartis has announced that the Phase 3 QUARTZ study met its primary and secondary endpoints, demonstrating that low dose QMF149 indacaterol/mometasone furoate delivered via the Breezhaler DPI produced statistically significant and clinically meaningful lung function and asthma control improvements compared to mometasone furoate alone in adult and adolescent patients … [Read more...] about Phase 3 trial of QVM149 meets primary and secondary endpoints
BlueWillow announces US patent for intranasal anthrax vaccine
According to BlueWillow Biologics, the University of Michigan has been issued US patent No. 10,138,279 which covers an intranasal anthrax vaccine formulated with BlueWillow's NanoVax adjuvant. BlueWillow (formerly NanoBio) is a spin out from the University of Michigan and has an exclusive license to the anthrax vaccine. The company said that its partner … [Read more...] about BlueWillow announces US patent for intranasal anthrax vaccine
According to Vectura and Sosei, Novartis has filed MAA for triple therapy DPI
Vectura Group and Sosei Group each said that they are owed $2.5 million milestone payments from Novartis after the EU accepted Novartis's MAA for its QVM149 indacaterol/glycopyrronium/mometasone furoate DPI for the treatment of asthma that is inadequately controlled. Vectura said that approval of the MAA would trigger an additional milestone payment of $5 million. … [Read more...] about According to Vectura and Sosei, Novartis has filed MAA for triple therapy DPI
Study finds as-needed budesonide/formoterol superior to as-needed albuterol (salbutamol) for reducing risk of severe exacerbations in mild asthma
A study published May 19, 2019 in the New England Journal of Medicine found that the Symbicort Turbuhaler budesonide/formoterol DPI demonstrated a greater than 50% reduction in the risk of asthma exacerbations in mild asthma patients compared to as-needed albuterol (salbutamol) alone. Compared to as-needed albuterol used in conjunction with maintenance budesonide, … [Read more...] about Study finds as-needed budesonide/formoterol superior to as-needed albuterol (salbutamol) for reducing risk of severe exacerbations in mild asthma
Respivant initiates Phase 2b study of RVT-1601 for IPF cough
Respivant Sciences has announced dosing of the first patient in the Phase 2b SCENIC trial of its RVT-1601 cromolyn sodium inhalation solution for the treatment of cough in idiopathic pulmonary fibrosis (IPF) patients. Respivant was spun off from Roivant in September 2018 specifically to develop RVT-1601. Roivant acquired the cromolyn sodium inhalation solution, … [Read more...] about Respivant initiates Phase 2b study of RVT-1601 for IPF cough