News
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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)… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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The FDA has approved Neurelis’s Valtoco diazepam nasal spray for the treatment of seizure clusters or acute repetitive seizures in epilepsy patients aged 6 years and older. Neurelis submitted the 505(b)(2) NDA for Valtoco in… Read more . . .
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