Medical Developments International (MVP) has announced that Health Canada has accepted its submission for the Penthrox methoxyflurane inhaler, triggering a $250,000 Canadian milestone payment to MVP from Purdue Pharma Canada. In September 2016, MVP announced that Purdue Pharma Canada would pay $3 million Canadian for Canadian rights to Penthrox for the treatment of … [Read more...] about Health Canada accepts Penthrox regulatory submission for review
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FDA accepts Sandoz’s ANDA for generic version of Advair Diskus
According to Novartis, the FDA has accepted Sandoz's abbreviated new drug application for its generic version of the Advair Discus (Seretide Accuhaler) fluticasone propionate/salmeterol DPI for the treatment of asthma and COPD. The company acquired the product when it acquired Oriel Therapeutics in 2010. In October 2016, Sandoz filed a citizen petition with the … [Read more...] about FDA accepts Sandoz’s ANDA for generic version of Advair Diskus
21st ISAM Congress focused on emerging trends
The 21st Congress of the International Society for Aerosols in Medicine (ISAM), held in Santa Fe, New Mexico June 3-7, 2017 featured presentations and posters covering recent advances in a wide range of topics related to aerosol drug delivery, including novel methods of modeling, trends in device design, and new therapies, and several new devices were on display in … [Read more...] about 21st ISAM Congress focused on emerging trends
SPARC announces top line results of pivotal trial of SPARC DPI, a generic version of Seretide Accuhaler/Advair Diskus
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
Pulmatrix licenses kinase inhibitors from RespiVert
Inhaled drug developer Pulmatrix announced that it has licensed a portfolio of kinase inhibitors from Janssen Biotech subsidiary RespiVert that it plans to develop as inhaled therapies for respiratory diseases. According to a form filed with the US Securities and Exchange Commission (SEC), Pulmatrix will pay $1 million up front plus milestones ranging from $1-80 … [Read more...] about Pulmatrix licenses kinase inhibitors from RespiVert
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
Windtree partners with Lee’s Pharm for development of Aerosurf in Asia
Windtree Therapeutics has signed an agreement with Hong-Kong based Lee's Pharmaceutical Limited for the development and commercialization of Aerosurf and other KL4 surfactant products in a number of Asian countries, the company said. Lee's will also have the right to manufacture KL4 surfactants in China, but aerosol products are excluded from that license. In … [Read more...] about Windtree partners with Lee’s Pharm for development of Aerosurf in Asia
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
Adherium appoints Arik Anderson as Group CEO
Smartinhaler manufacturer Adherium Limited has appointed Arik Anderson as Group CEO, the company said. He succeeds company founder Garth Sutherland, who will stay on as an Executive Director on the board. Anderson, who was most recently President of Perfusion and Surgical Devices at Terumo Cardiovascular Systems, has more than 25 years of experience working at … [Read more...] about Adherium appoints Arik Anderson as Group CEO
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