According to Emergent BioSolutions, the shelf life for newly manufactured Narcan naloxone nasal spray has been extended to 48 months; the previous shelf life was 36 months. Narcan has been approved for the reversal of opioid overdose in Canada since October 2016. Emergent Senior VP, Head of Products Business, Paul Williams commented, “Helping to save lives from … [Read more...] about Emergent BioSolutions’ Narcan naloxone nasal spray gets shelf-life extension in Canada
Medical
FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
According to NeOnc Technologies, the FDA has approved an expansion of an ongoing Phase 2a trial of the company's NEO100 intranasal perillyl alcohol to include patients with recurrent grade 3 astrocytoma with isocitrate dehydrogenase 1 (IDH1) mutation. NeOnc announced the initiation of the trial, which initially focused on treatment of grade 4 gliomas, in May 2016. The … [Read more...] about FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
UTMB researchers publish preclinical data on intranasal mAb to prevent Tau accumulation in the brain
The University of Texas Medical Branch announced publication of an article in Science Translational Medicine by UTMB researchers who are developing an intranasal toxic tau conformation–specific monoclonal antibody-2 (TTCM2) to prevent the accumulation of tau protein in the brain. The article describes successful intranasal delivery of TTCM2 loaded in micelles to the … [Read more...] about UTMB researchers publish preclinical data on intranasal mAb to prevent Tau accumulation in the brain
Tiziana says the FDA has approved use of intranasal foralumab in Alzheimer’s patients under an expanded access IND
Tiziana Life Sciences announced that it will dose a patient with moderate Alzheimer’s disease with intranasal foralumab under an expanded access IND. The company previously used the expanded access program to provide intranasal foralumab to multiple sclerosis patients at Brigham and Women’s Hospital and for home use before initiating a Phase 2a trial of foralumab for … [Read more...] about Tiziana says the FDA has approved use of intranasal foralumab in Alzheimer’s patients under an expanded access IND
Phase 3 IMPALA-2 trial of Savara’s inhaled mogramostim in aPAP patients meets primary endpoint
Savara has announced that the Phase 3 IMPALA-2 trial of molgramostim nebulized recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with autoimmune pulmonary alveolar proteinosis (aPAP) met its primary endpoint, achieving statistically significant change in percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) … [Read more...] about Phase 3 IMPALA-2 trial of Savara’s inhaled mogramostim in aPAP patients meets primary endpoint
MannKind says Phase 4 INHALE-3 study of Afrezza insulin DPI met its primary endpoint
MannKind Corporation announced that the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics met its primary endpoint, with 30% of participants using Afrezza achieving an HbA1c level of less than 7% at 17 weeks compared to 17% of the usual care group. The company, which announced some data from the … [Read more...] about MannKind says Phase 4 INHALE-3 study of Afrezza insulin DPI met its primary endpoint
Phase 2b trial of Aerovate’s AV-101 imatinib DPI in PAH patients fails to meet primary endpoint
Aerovate Therapeutics says that the Phase 2b portion of the Phase 2b/3 IMPAHCT trial of the company's AV-101 inhaled dry powder imatinib in patients with pulmonary arterial hypertension (PAH) failed to meet its primary endpoint of change in pulmonary vascular resistance compared to placebo for any of the doses studied. The IMPAHCT trial was initiated in December … [Read more...] about Phase 2b trial of Aerovate’s AV-101 imatinib DPI in PAH patients fails to meet primary endpoint
BARDA awards ~$40 million to CyanVac and ~$34 million to CastleVax for Phase 2b trials of intranasal COVID-19 vaccines
The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), announced that it has awarded approximately $40 million to CyanVac and approximately $34 million to CastleVax to support Phase 2b clinical trials of the companies' intranasal COVID-19 vaccine candidates. Each of the Phase 2b trials will … [Read more...] about BARDA awards ~$40 million to CyanVac and ~$34 million to CastleVax for Phase 2b trials of intranasal COVID-19 vaccines
Cessatech initiates Phase 3 pediatric trial of CT001 sufentanil / ketamine nasal spray for acute pain
According to Rigshospitalet spin-out Cessatech, the company has initiated a Phase 3 trial of its CT001 sufentanil / ketamine nasal spray in children seen in the emergency department with moderate to severe pain. In July 2022, Cessatech announced plans for the 0205 trial of CT001 in adult patients following extraction of wisdom teeth, and the company reported results … [Read more...] about Cessatech initiates Phase 3 pediatric trial of CT001 sufentanil / ketamine nasal spray for acute pain
Celon Pharma announces creation of Novohale Therapeutics in partnership with Tang Capital, Phase 3 development of Falkieri esketamine DPI
Celon Pharma has disclosed a deal in which it will invest $20 million over 2 years, and Tang Capital will invest $10 million over that same period, in a new US-based company called Novohale Therapeutics that will initiate Phase 3 development of Celon's Falkieri esketamine DPI for the treatment of bipolar depression. Celon's marketed products include the Salmex … [Read more...] about Celon Pharma announces creation of Novohale Therapeutics in partnership with Tang Capital, Phase 3 development of Falkieri esketamine DPI