Transpire Bio has announced the initiation of its clinical program for a generic inhaler for the treatment of asthma and COPD. The company did not specify which of its pipeline products has been advanced into Phase 1. According to Transpire Bio's web site, the company's pipeline includes both a DPI and an MDI for asthma/COPD in addition to a DPI and SMIs for COPD. … [Read more...] about Transpire Bio announces initiation of Phase 1 study of generic inhaler for asthma and COPD
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InCarda says development of FlecIH-103 flecainide inhalation solution will continue despite early termination of Phase 3 trial
According to InCarda, data from the Phase 3 RESTORE-1 trial of FlecIH-103 flecainide inhalation solution for aroxysmal atrial fibrillation (PAF), which was initiated in July 2022, support continued development despite the early termination of the study due to disappointing efficacy and plasma concentrations. InCarda cites delivery problems with the jet nebulizer used … [Read more...] about InCarda says development of FlecIH-103 flecainide inhalation solution will continue despite early termination of Phase 3 trial
Vistagen initiates Phase 3 PALISADE-4 trial of fasedienol nasal spray for social anxiety disorder
Vistagen has announced the initiation of the Phase 3 PALISADE-4 trial of fasedienol pherine nasal spray in people with social anxiety disorder (SAD). According to the company, the PALISADE-4 trial is similar to the PALISADE-3 trial, which was initiated earlier this year. Both of those studies have protocols that are similar to the PALISADE-2 trial, which the company … [Read more...] about Vistagen initiates Phase 3 PALISADE-4 trial of fasedienol nasal spray for social anxiety disorder
FDA warns agains use of Green Pharmaceutical’s SnoreStop nasal spray due to microbial contamination
The FDA has advised California-based Green Pharmaceuticals to recall its SnoreStop nasal spray due to "significant microbial contamination in SnoreStop Nasal Spray lot number 2460" detected during an inspection in April 2024 and is warning customers not to use the product. The FDA notes that the homeopathic product is unapproved and that Green previously recalled a … [Read more...] about FDA warns agains use of Green Pharmaceutical’s SnoreStop nasal spray due to microbial contamination
Tiziana announces $4 million NIH grant for study of intranasal foralumab for Alzheimer’s disease
Tiziana Life Sciences announced that a study of the company's intranasal anti-CD3 mAb will be funded by a $4 million grant from the National Institutes of Health. In June 2024, the company said that the FDA had approved the use of intranasal foralumab in a patient with moderate Alzheimer’s disease under an expanded access IND. Tiziana said that it anticipates … [Read more...] about Tiziana announces $4 million NIH grant for study of intranasal foralumab for Alzheimer’s disease
MannKind gets go-ahead for Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension in for NTM Japan
MannKind Corporation announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the initiation of the Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease. The company noted that the trial has already been cleared in the US, South Korea, and Australia; and … [Read more...] about MannKind gets go-ahead for Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension in for NTM Japan
TFF Pharmaceuticals partners with Emory University on mRNA-based antiviral DPI with BARDA funding
TFF Pharmaceuticals announced that it will study the feasibility of formulating Emory University's mRNA-based Cas13a antiviral for the treatment of SARS-CoV-2 and influenza A and B as a dry powder using the company's thin film freezing technology. Funding for the study is provided by the Biomedical Advanced Research and Development Authority (BARDA) as part of its … [Read more...] about TFF Pharmaceuticals partners with Emory University on mRNA-based antiviral DPI with BARDA funding
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
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