Respira Therapeutics has announced that United Therapeutics will end its collaboration with the company and will return all rights to Respira's RT234 vardenafil DPI, which is in Phase 2 development for the relief of symptoms of pulmonary arterial hypertension (PAH). The companies had announced the licensing deal and an investment by United Therapeutics in Respira in … [Read more...] about United Therapeutics returns rights to Respira’s RT234 vardenafil DPI
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Experic names Sherry Ann D’Iorio as Executive Director of Business Development
Contract manufacturer Experic, which offers a variety of services related to dry powder inhalers, has named Sherry Ann D’Iorio as Executive Director of Business Development. D'Iorio was most recently Senior Account Director of Business Development at PPD and has previously held positions at a number of life sciences companies, including Worldwide Clinical Trials, … [Read more...] about Experic names Sherry Ann D’Iorio as Executive Director of Business Development
English High Court dismisses GSK claims in AirFluSal Forspiro case
According to Vectura, the English High Court has dismissed all claims in a "passing off" case brought by GlaxoSmithKline in which GSK charged that of Sandoz's AirFluSal Forspiro DPI looks too similar to Seretide Accuhaler. Both inhalers and their packaging feature a similar shade of purple. Vectura noted that GSK has filed similar cases in a number of European … [Read more...] about English High Court dismisses GSK claims in AirFluSal Forspiro case
Milestone Pharmaceuticals initiates Phase 3 safety study of intranasal etripamil for PVST
Milestone Pharmaceuticals has announced the initiation of the Phase 3 NODE-303 open-label safety study of the company's intranasal etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). NODE-303 is the third of three trials in the Phase 3 program for etripamil. NODE-301 was initiated in August 2018, and NODE-302 got underway in December 2018. … [Read more...] about Milestone Pharmaceuticals initiates Phase 3 safety study of intranasal etripamil for PVST
Janssen submits sNDA for Spravato nasal spray
Janssen Pharmaceutical said that it has submitted a supplemental new drug application to the FDA requesting to expand the use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder in patients with active suicidal ideation with intent. The company recently published positive results from the Phase 3 ASPIRE 1 and 2 studies of Spravato … [Read more...] about Janssen submits sNDA for Spravato nasal spray
Chiesi reports positive results from Phase 3 studies of extrafine triple combination MDI
Chiesi Farmaceutici has announced results from the Phase 3 TRIGGER and TRIMARAN studies of its CHF 5993 extrafine beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium (G) MDI for the treatment of uncontrolled asthma in patients who have had at least one exacerbation in the past year. CHF 5993, also known as Riarify, contains the same three drugs as … [Read more...] about Chiesi reports positive results from Phase 3 studies of extrafine triple combination MDI
GSK submits sNDA for Trelegy Ellipta for the treatment of asthma
GlaxoSmithKline and Innoviva announced that GSK has submitted a supplemental new drug application for the use of the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of asthma. The FDA initially approved Trelegy Ellipta for the treatment of COPD in September 2017 and approved an sNDA to expand the indication for wider use of the DPI … [Read more...] about GSK submits sNDA for Trelegy Ellipta for the treatment of asthma
FDA discourages BLA submission for Mogradex for aPAP
Savara said that the FDA provided a written response after a Type C meeting regarding the company's planned biologics license application (BLA) submission for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) in which the agency recommended against … [Read more...] about FDA discourages BLA submission for Mogradex for aPAP
Upsher-Smith launches Tosymra nasal spray in the US
Upsher-Smith has announced the US launch of Tosymra sumatriptan nasal spray. The FDA approved Tosymra for the treatment of migraine with or without aura in January 2019, and Upsher-Smith acquired US rights to the nasal spray from Promius Pharma in June 2019. The Tosymra formulation uses Intravail transmucosal absorption enhancement technology and is delivered via … [Read more...] about Upsher-Smith launches Tosymra nasal spray in the US
Health Canada approves use of Symbicort Turbuhaler as anti-inflammatory reliever for mild persistent asthma
AstraZeneca Canada has announced today that Health Canada has approved the use of Symbicort Turbuhaler budesonide/formoterol DPI as an anti-inflammatory reliever for the treatment of mild persistent asthma. According to the company, the expanded use was based on data from the Phase 3 SYGMA 1 and 2 trials. AstraZeneca Canada VP, Scientific … [Read more...] about Health Canada approves use of Symbicort Turbuhaler as anti-inflammatory reliever for mild persistent asthma