Sun Pharma Advanced Research Company Ltd. (SPARC) has announced that its SPARC DPI salmeterol 25 µg/fluticasone propionate 50 µg dry powder inhaler failed to show bioequivalence to Seretide Accuhaler (Advair Diskus) salmeterol 50 µg/fluticasone propionate 100 µg in a pivotal study because the peak concentration of salmeterol for patients using the SPARC DPI was higher … [Read more...] about SPARC announces top line results of pivotal trial of SPARC DPI, a generic version of Seretide Accuhaler/Advair Diskus
Medical
Pharmaxis announces results from Phase 3 trial of Bronchitol mannitol DPI for CF
Pharmaxis has announced that its pivotal Phase 3 trial of Bronchitol mannitol DPI in adult patients with cystic fibrosis met its primary endpoint of change in FEV1 from baseline over the 26-week treatment period; however the company said that the improvement was less than that reported in previous Phase 3 studies in adults. Pharmaxis, which is partnered with … [Read more...] about Pharmaxis announces results from Phase 3 trial of Bronchitol mannitol DPI for CF
Ventaleon presents data from Phase 2 study of inhaled LASAG for severe influenza
German biotech Ventaleon, a spin-off of Activaero, which was acquired by Vectura in 2014, presented data from a Phase 2 trial of inhaled D, L-lysine acetylsalicylate glycine (LASAG) in severe influenza at the recent ISAM Congress that show inhibition of a signaling factor required for flu virus replication. The double-blind placebo-controlled study, in 41 … [Read more...] about Ventaleon presents data from Phase 2 study of inhaled LASAG for severe influenza
Phase 2 study of Promius Pharma’s intranasal sumatriptan meets primary endpoint
Dr. Reddy's subsidiary Promius Pharma has announced that a Phase 2 study of its DFN-02 intranasal sumatriptan for the treatment of migraine met its primary endpoint, the proportion of subjects free of migraine pain at 2 hours post dose. After 2 hours, 43.8% of patients treated with DFN-02 experienced migraine pain relief compared to 22.5% of patients who received … [Read more...] about Phase 2 study of Promius Pharma’s intranasal sumatriptan meets primary endpoint
InCarda announces positive Phase 1 results for inhaled flecainide
InCarda Therapeutics has announced that a Phase 1 study of InRhythm inhaled flecainide, which it is developing for the treatment of paroxysmal atrial fibrillation (PAF), met its primary and secondary endpoints, with all doses found to be safe and well tolerated and achieving effective plasma levels within 3 minutes. In 2015, InCarda established an Australian … [Read more...] about InCarda announces positive Phase 1 results for inhaled flecainide
Vectura reports positive Phase 1 results for VR942 inhaled biologic
Vectura has announced that it is presenting positive results from a Phase I clinical study of VR942, an inhaled anti-IL-13 monoclonal fragment antibody, at the American Thoracic Society 2017 International Conference. Vectura is partnered with UCB to develop VR942 as a treatment for severe asthma, and the companies expect to begin a Phase 2 study in the second half of … [Read more...] about Vectura reports positive Phase 1 results for VR942 inhaled biologic
Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial
Acorda Therapeutics will present new data from a Phase 3 trial of its CVT-301 inhaled L-dopa, which it is now calling Inbrija, at the International Congress of Parkinson’s Disease and Movement Disorders (MDS). The company has previously said that data from the Phase 3 SPAN-PD trial show that CVT-301 significantly improves motor function in Parkinson's Disease … [Read more...] about Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial
Positive Phase 2 results for Milestone’s intranasal etripamil
Milestone Pharmaceuticals has announced positive results from the Phase 2 NODE-1 study of intranasal etripamil for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT), a type of cardiac arrhythmia. The double-blind dose ranging study enrolled 104 patients who received 1 of 4 doses of intranasal etripamil or placebo after an induced PSVT … [Read more...] about Positive Phase 2 results for Milestone’s intranasal etripamil
Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
The IMPALA Phase 2/3 trial for Savara's Molgradex inhaled molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) will be modified in order to qualify as a pivotal study for a US regulatory submission, the company said. According to Savara, the FDA has provided guidance on increasing enrollment and changing endpoint hierarchy and analysis … [Read more...] about Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
Salford Lung Study data show increased effectiveness of Relvar Ellipta for asthma compared to usual care
GlaxoSmithKline and Innoviva have announced that data from the real world Salford Lung Study show that asthma patients using Relvar (Breo) Ellipa fluticasone furoate/vilanterol 100/25μg or 200/25μg had improved asthma control compared to those using their usual care, either ICS or ICS/LABA combinations. Relvar Ellipta was approved for the treatment of asthma in the … [Read more...] about Salford Lung Study data show increased effectiveness of Relvar Ellipta for asthma compared to usual care