Liquidia Technologies said that it has submitted a 505(b)(2) NDA for its LIQ861 inhaled dry powder treprostinil for the treatment of pulmonary arterial hypertension (PAH). The company announced in March 2019 that the Phase 3 INSPIRE trial of LIQ861 had met its primary endpoint. Liquidia CEO Neal Fowler commented, "The submission of the NDA for LIQ861 in the US is … [Read more...] about Liquidia submits NDA for LIQ861 treprostinil DPI for the treatment of PAH
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CapMedic inhaler sensor gets FDA clearance
Cognita Labs has received FDA clearance for its CapMedic digital inhaler sensor for use with metered dose inhalers, the company said. The CapMedic device, which fits over the top of the MDI actuator and includes a built in spirometer, provides audio and visual instruction to patients to encourage correct inhaler use. The device also connects to a smartphone app, … [Read more...] about CapMedic inhaler sensor gets FDA clearance
Evoke announces commercialization deal with Eversana for Gimoti nasal spray
Days after announcing that the FDA has accepted its NDA resubmission for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, Evoke Pharma said that the company has cancelled a previously announced commercialization deal with Novus Growth Partners and has signed a new 5-year deal with Eversana for commercialization and distribution of Gimoti … [Read more...] about Evoke announces commercialization deal with Eversana for Gimoti nasal spray
Baqsimi intranasal glucagon approved in Canada
Health Canada has approved Baqsimi intranasal dry powder glucagon for the treatment of severe hypoglycemia in patients with Type 1 or Type 2 diabetes, Eli Lilly Canada has announced. Baqsimi is now available in Canadian pharmacies with or without a prescription. Lilly acquired worldwide rights to the intranasal glucagon formulation from Locemia, which is based in … [Read more...] about Baqsimi intranasal glucagon approved in Canada
AstraZeneca announces plans for “next-generation inhaler” as part of “Ambition Zero Carbon” program
AstraZeneca has announced a commitment to launching a "next-generation" MDI with minimal global warming potential (GWP) propellants by 2025 as part of its $1 billion "Ambition Zero Carbon" program. The new program, which was announced at the World Economic Forum meeting in Davos, Switzerland, aims for zero carbon emissions by 2025 and a carbon negative value chain by … [Read more...] about AstraZeneca announces plans for “next-generation inhaler” as part of “Ambition Zero Carbon” program
FDA accepts resubmitted NDA for Gimoti nasal spray
According to Evoke Pharma, the FDA has accepted its resubmitted NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis and has set a PDUFA date of June 19, 2020. The original 505(b)(2) NDA was submitted in June 2018, and the FDA issued a complete response letter to that NDA in April 2019. Evoke announced in December 2019 that it had … [Read more...] about FDA accepts resubmitted NDA for Gimoti nasal spray
Impel NeuroPharma appoints Sheena K. Aurora as VP of Medical Affairs, Migraine Franchise
Impel NeuroPharma has announced the appointment of Sheena K. Aurora as VP of Medical Affairs, Migraine Franchise. Aurora will handle medical affairs strategy for Impel's INP104 intranasal intranasal dihydroergotamine (DHE) for the treatment of acute migraine. The company announced the initiation of the Phase 3 STOP-301 study of INP104 in August 2018. Aurora was … [Read more...] about Impel NeuroPharma appoints Sheena K. Aurora as VP of Medical Affairs, Migraine Franchise
Virpax to develop intranasal enkephalin formulation for the treatment of PTSD
Virpax Pharmaceuticals announced that it has acquired exclusive global rights from Nanomerics Ltd. for the use of molecular envelope technology (MET) for delivery of an intranasal formulation of enkephalin for the treatment of PTSD. The company says that PES200 will be delivered via a cartridge-based, pressurized nasal delivery device, presumably the Naltos dry … [Read more...] about Virpax to develop intranasal enkephalin formulation for the treatment of PTSD
Janssen submits type II variation application for Spravato
Janssen Pharmaceutical announced that the company has submitted a type II variation application for Spravato esketamine nasal spray to the EMA seeking to expand the use of Spravato for the treatment of major depressive disorder (MDD) in patients who have active suicidal ideation with intent. Spravato was approved in Europe in December 2019 for the treatment of … [Read more...] about Janssen submits type II variation application for Spravato
Positive results for Phase 2b trial of nebulized ensifentrine as add-on to tiotropium
Verona Pharma said that a Phase 2b dose-ranging study of its RPL554 nebulized ensifentrine as an add on to tiotropium for the treatment of COPD met its primary endpoint at all doses tested. The company had announced initiation of the study in May 2019. The 4 week study, which enrolled 416 moderate-to-severe COPD patients, compared 0.375 mg, 0.75 mg, 1.5 mg, and … [Read more...] about Positive results for Phase 2b trial of nebulized ensifentrine as add-on to tiotropium