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
News
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
Pulmotect names Colin Broom as CEO
Texas-based Pulmotect, which is developing an inhaled immune stimulant for the treatment of respiratory diseases, has announced the appointment of Colin Broom as CEO. Broom was most recently CEO of Nabriva Therapeutics and previously served as Chief Scientific Officer at ViroPharma and in various roles at Amgen, Aventis, and GSK. Pulmotect is a spin out of … [Read more...] about Pulmotect names Colin Broom as CEO
AstraZeneca gets CRL for PT010
According to AstraZeneca, the FDA has issued a complete response letter to the company's NDA for PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of COPD. AstraZeneca recently announced positive results from the Phase 3 ETHOS trial of PT010 and said that the MDI had been approved in Japan as Breztri Aerosphere. Results from the ETHOS trial … [Read more...] about AstraZeneca gets CRL for PT010
Lannett makes deal for distribution of generic Advair in US
Lannett said that it has signed a US distribution agreement for rights to Respirent Pharmaceuticals' generic Advair Diskus. The agreement would begin after FDA approval and would continue for 10 years after distribution begins. Lannett said that it would pay an unspecified upfront payment and future milestones and that it would receive a portion of net profits during … [Read more...] about Lannett makes deal for distribution of generic Advair in US