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Seelos Therapeutics sets Type C meeting with FDA regarding SLS-002 intranasal racemic ketamine

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 and behavior (ASIB) in patients with major depressive disorder (MDD). The FDA granted Fast Track designation to SLS-002 in November 2019. According to the … [Read more...] about Seelos Therapeutics sets Type C meeting with FDA regarding SLS-002 intranasal racemic ketamine

Pulmatrix announces collaboration with Nocion Therapeutics

Two months after announcing the appointment of Nocion Therapeutics CEO Rick Batycky to its board, Pulmatrix has announced a deal with Nocion to look at the use of Pulmatrix's iSPERSE particle engineering technology for development of inhaled formulations of Nocion drugs.  According to the Nocion web site, the company's lead candidate targets refractory chronic cough. … [Read more...] about Pulmatrix announces collaboration with Nocion Therapeutics

ATAI Life Sciences partners with Neuronasal on intranasal N-acetylcysteine for concussion

ATAI Life Sciences has announced a deal with US-based Neuronasal Inc. for development of intranasal N-acetylcysteine (NAC) for the treatment of mild traumatic brain injury (mTBI, or concussion). ATAI said that it expects initiation of a pilot study in healthy volunteers in February 2020. According to a Neuronasal presentation, the drug would be delivered via the … [Read more...] about ATAI Life Sciences partners with Neuronasal on intranasal N-acetylcysteine for concussion

Pulmatrix announces license agreement with J&J’s Lung Cancer Initiative

According to Pulmatrix, the Lung Cancer Initiative at Johnson & Johnson will pay $7.2 million up front plus a $2 million milestone payment for an option "to access a portfolio of narrow spectrum kinase inhibitors intended for development in lung cancer interception." The $2 million milestone payment will be due on completion of a Phase 1b study of RV1162/PUR1800 … [Read more...] about Pulmatrix announces license agreement with J&J’s Lung Cancer Initiative

CF PharmTech gets $90 million in latest financing round for inhaled drug development

CF PharmTech, which says it is developing a variety of OINDPs, announced that it has closed a Series E financing round  that will be used to support development of its pipeline products. The $90 million round was led by Shanghai-based New Alliance Capital. In August 2017, the company said that it had raised $65 million in a Series D round to support development … [Read more...] about CF PharmTech gets $90 million in latest financing round for inhaled drug development

FDA grants Breakthrough Therapy designation for Molgradex for aPAP

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 3 IMPALA study of Molgradex for that indication had failed to meet its … [Read more...] about FDA grants Breakthrough Therapy designation for Molgradex for aPAP

AstraZeneca’s triple combination MDI approved in China for treatment of COPD

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. According to AstraZeneca, the approval was based on results from the Phase 3 KRONOS trial, which had a primary … [Read more...] about AstraZeneca’s triple combination MDI approved in China for treatment of COPD