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
Medical
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
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
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