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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

ENA Respiratory announces advancement into Phase 1b study of INNA-051 intranasal dry powder antiviral

ENA Respiratory announced that it has completed a Phase 1a study and has initiated a Phase 1b study of its INNA-051 TLR2/6 agonist pan-viral nasal powder in people aged 60 and older. Earlier this year, the company announced that the FDA had cleared an IND for the Phase 1b trial. According to the company, the new trial is expected to enroll up to 40 … [Read more...] about ENA Respiratory announces advancement into Phase 1b study of INNA-051 intranasal dry powder antiviral

ARS Pharma’s EURneffy adrenaline nasal spray approved in Europe

ARS Pharmaceuticals announced that the European Commission has approved the company's EURneffy adrenaline nasal spray for the treatment of anaphylaxis. The approval comes soon after the FDA's approval of the US version, Neffy epinephrine nasal spray. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the EURneffy MAA in … [Read more...] about ARS Pharma’s EURneffy adrenaline nasal spray approved in Europe

Liquidia files suit to challenge FDA’s grant of exclusivity to Tyvaso DPI in ongoing litigation over Yutrepia DPI approval

Soon after the FDA granted temporary approval to Liquidia's sNDA for Yutrepia treprostinil DPI, the company announced that it has filed a lawsuit challenging the FDA's grant of 3-year new clinical investigation exclusivity to United Therapeutics' Tyvaso treprostinil DPI, which is standing in the way of final approval of Yutrepia. Exclusivity for Tyvaso DPI is … [Read more...] about Liquidia files suit to challenge FDA’s grant of exclusivity to Tyvaso DPI in ongoing litigation over Yutrepia DPI approval