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Roivant’s Pulmovant subsidiary developing mosliciguat DPI licensed from Bayer for the treatment of PH-ILD

Roivant has revealed that its Pulmovant subsidiary is developing inhaled dry powder mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), and Pulmovant presented a poster with data from the Phase 1b ATMOS study of mosliciguat at the 2024 ERS Congress. Roivant says that it paid approximately $14 million up front … [Read more...] about Roivant’s Pulmovant subsidiary developing mosliciguat DPI licensed from Bayer for the treatment of PH-ILD

Silo Pharma says that it completed pre-IND meeting with the FDA regarding SPC-15 intranasal ketamine for PTSD and anxiety

Silo Pharma announced that it has received responses from the FDA following a pre-IND meeting regarding SPC-15 soft mist intranasal ketamine for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder. Silo is planning to take advantage of the 505(b)(2) pathway for SPC-15, which it has licensed from Columbia University. In November 2023, Silo … [Read more...] about Silo Pharma says that it completed pre-IND meeting with the FDA regarding SPC-15 intranasal ketamine for PTSD and anxiety

Aptar Pharma to offer services for development projects based on Pulmotree’s Kolibri nebulizer platform

Aptar Pharma announced that it has signed a development and promotion agreement with Pulmotree related to Pulmotree's Kolibri mesh nebulizer, which it refers to as a non-propellant liquid inhaler (NPLI) platform. The company says that its subsidiaries, including inhalation CRO Nanopharm and human factors specialist Noble, will support Kolibri development projects for … [Read more...] about Aptar Pharma to offer services for development projects based on Pulmotree’s Kolibri nebulizer platform

AstraZeneca says that it has completed studies to support regulatory submissions for LGWP propellant version of Breztri (Trixeo) Aerosphere MDI

AstraZeneca announced that it now has the data to support regulatory submissions for a new formulation of of Breztri (Trixeo) Aerosphere budesonide / glycopyrronium / formoterol using Honeywell's Solstice Air HFO 1234ze(e), a low global warming potential (LGWP) propellant. The company says that it now plans to initiate submissions for the reformulated MDI by the end … [Read more...] about AstraZeneca says that it has completed studies to support regulatory submissions for LGWP propellant version of Breztri (Trixeo) Aerosphere MDI

ARS Pharmaceuticals submits sNDA for Neffy 1 mg epinephrine nasal spray for anaphylaxis in small children

ARS Pharmaceuticals announced that it has submitted a supplemental NDA for Neffy 1 mg epinephrine nasal spray for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs). The FDA recently approved a 2 mg dose of Neffy for the treatment of anaphylaxis in patients weighing 30 kg or more. At that time, the company said that it intended to submit the … [Read more...] about ARS Pharmaceuticals submits sNDA for Neffy 1 mg epinephrine nasal spray for anaphylaxis in small children

Ji Xing’s Chinese Phase 3 trial of Milestone’s etripamil nasal spray meets primary endpoint

According to Milestone Pharmaceuticals, a Phase 3 trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) that was conducted by Ji Xing Pharmaceuticals in China met its primary endpoint of the proportion of patients converting to sinus rhythm within 30 minutes post-dose. Ji Xing acquired the Chinese rights to etripamil for PVST … [Read more...] about Ji Xing’s Chinese Phase 3 trial of Milestone’s etripamil nasal spray meets primary endpoint

ENA Respiratory gets additional funding from the US Department of Defense for development of INNA-051 intranasal antiviral

ENA Respiratory announced that it has received a contract extension from the US Department of Defense (DoD), providing additional funds for continued development of INNA-051, a dry powder intranasal TLR2/6 agonist. In January 2023, ENA Respiratory announced that the DoD had provided funding to develop a dry powder formulation of the antiviral, which had previously … [Read more...] about ENA Respiratory gets additional funding from the US Department of Defense for development of INNA-051 intranasal antiviral

Avalyn iniates Phase 2b MIST study of AP01 inhaled pirfenidone in PPF patients

Avalyn Pharma has announced the initiation of the Phase 2b MIST study of AP01 pirfenidone inhalation solution in patients with progressive pulmonary fibrosis (PPF). In March 2023, the company announced that a Phase 1b trial of nebulized AP01 in IPF patients demonstrated a significant reduction in the progression of the disease, with lung function in most patients … [Read more...] about Avalyn iniates Phase 2b MIST study of AP01 inhaled pirfenidone in PPF patients

FDA clears IND for Phase 2 trial of Arcturus’ ARCT-032 inhaled mRNA therapy in CF patients

According to Arcturus Therapeutics, the FDA has cleared an investigational new drug application allowing the company to proceed with a Phase 2 MAD trial of its ARCT-032 inhaled mRNA therapy in people with cystic fibrosis. The nebulized therapy, which is designed to deliver CFTR mRNA, has both orphan drug and rare pediatric disease designations from the FDA and orphan … [Read more...] about FDA clears IND for Phase 2 trial of Arcturus’ ARCT-032 inhaled mRNA therapy in CF patients