Regulatory
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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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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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According to MannKind Corporation, Brazil’s Drug Market Regulation Chamber (CMED) has approved the proposed pricing for Afrezza inhaled insulin, and the Afrezza DPI is set to launch in Brazil within the next week. The Brazilian Health… Read more . . .
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Seelos Therapeutics said that it has scheduled a Type C meeting with the FDA for March 2020 regarding a Phase 3 trial of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation… Read more . . .
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According to Savara, the FDA has granted Breakthrough Therapy designation for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). In June 2019, Savara announced that the Phase… Read more . . .
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AstraZeneca has announced that its PT010 budesonide/glycopyrronium/formoterol fumarate MDI has been approved by the Chinese National Medical Products Administration for the treatment of COPD. PT010 was approved in Japan as Breztri Aerosphere in June 2019.… Read more . . .
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According to Evoke Pharma, the company has resubmitted its 505(b)(2) for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. Evoke originally submitted the NDA for Gimoti in in June 2018 and announced that… Read more . . .
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Finnish nanonization specialists Nanoform have filed for GMP certification with the Finnish Medicines Agency (FIMEA), the company said. In December 2018, Nanoform announced construction of a new GMP manufacturing facility in Helsinki. The company, which… Read more . . .
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Australia’s Therapeutic Goods Administration has approved Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of allergic rhinitis and rhinoconjunctivitis, Glenmark Pharmaceuticals said. The marketing application was submitted by Seqirus, which acquired Australian commercialization rights to… Read more . . .
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The European Commission has approved Janssen Pharmaceutical’s Spravato esketamine nasal spray for the treatment of treatment-resistant major depressive disorder, the company said. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive… Read more . . .
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