Savara has discontinued development of Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection and will not restart the Phase 2a ENCORE study of Molgradex for NTM in cystic fibrosis patients, the company said. Development of Molgradex for the treatment of … [Read more...] about Savara discontinues development of Molgradex for NTM lung infections
Medical
MediciNova announces development plans for intranasal SARS-CoV-2 vaccine
MediciNova said that it has tested a number of intranasal SARS-CoV-2 vaccine prototypes using a viral vector technology platform from Mie University and BioComo and has identified several candidates that it plans to advance. BioComo's BC-PIV vaccine carrier is based on recombinant human parainfluenza virus 2 (hPIV2) vectors. According to MediciNova, the intranasal … [Read more...] about MediciNova announces development plans for intranasal SARS-CoV-2 vaccine
Partner Therapeutics initiates Phase 2 trial of inhaled sargramostim for COVID-19
Partner Therapeutics (PTx) has announced the initiation of the iLeukPulm Phase 2 trial of an inhaled formulation of its Leukine sargramostim in hospitalized COVID-19 patients in respiratory distress. Partner recently signed a $35 million contract with the US Department of Defense for development of Leukine for the treatment of COVID-19. PTx acquired Leukine, a … [Read more...] about Partner Therapeutics initiates Phase 2 trial of inhaled sargramostim for COVID-19
Additional positive preclinical data for Altimmune’s AdCOVID intranasal COVID-19 vaccine
Altimmune has announced that a preclinical study of its intranasal COVID-19 vaccine candidate AdCOVID has demonstrated a strong immune response in the lungs of mice, particularly in the stimulation of CD8+ T cells. In July 2020, Altimmune reported that several studies in a mouse model demonstrated a strong IgG and IgA responses. Altimmune is partnered with the … [Read more...] about Additional positive preclinical data for Altimmune’s AdCOVID intranasal COVID-19 vaccine
Union Therapeutics announces successful completion of Phase 1 trial of niclosamide DPI
Union Therapeutics said that a Phase 1 SAD/MAD trial of UNI911 dry powder niclosamide in 44 healthy volunteers was completed successfully, confirming the safety of the inhaled formulation. The company recently acquired an option for rights to the dry powder formulation from TFF Pharmaceuticals and intends to develop it as a DPI for the treatment of COVID-19. Union … [Read more...] about Union Therapeutics announces successful completion of Phase 1 trial of niclosamide DPI
Verona initiates Phase 2b trial of ensifentrine MDI for COPD
Verona Pharma has announced the initiation of a Phase 2b trial of its ensifentrine MDI for the treatment of COPD in the UK, with results expected in the first half of 2021. In March 2020, Verona announced positive results from a Phase 2a trial of the MDI and noted that the second part of the trial would be delayed due to the COVID-19 pandemic. The Phase 2b trial … [Read more...] about Verona initiates Phase 2b trial of ensifentrine MDI for COPD
Union Therapeutics acquires option for TFF’s dry powder niclosamide
Danish pharma company Union Therapeutics has entered into an agreement with TFF Pharmaceuticals for an option to license TFF's dry powder niclosamide, the companies announced. The deal includes potential inhaled and oral formulations of niclosamide for the treatment of COVID-19 and is worth up to $210 million in milestone payments as well as royalties on any … [Read more...] about Union Therapeutics acquires option for TFF’s dry powder niclosamide
Desmopressin nasal sprays recalled in US
Three weeks after recalling numerous lots of desmopressin nasal sprays in the UK and a number of other countries, Ferring has issued a recall of all lots of DDAVP 10 mcg/0.1ml, Stimate 1.5 mg/ml, and generic desmopressin 10 mcg/0.1ml nasal sprays in the US "due to superpotency or amounts of desmopressin higher than specified." The recall includes 6 lots of DDAVP, 15 … [Read more...] about Desmopressin nasal sprays recalled in US
Phase 3 trial of Levo’s intranasal carbetocin for PWS misses primary endpoint
A Phase 3 trial of Levo Therapeutics' LV-101 intranasal carbetocin in children with Prader-Willi Syndrome (PWS) failed to meet its primary endpoint, the company said. Enrollment in the study, which began in 2018, was stopped earlier than anticipated due to the COVID-19 pandemic, winding up with 119 patients in the primary analysis set. The CARE-PWS trial compared … [Read more...] about Phase 3 trial of Levo’s intranasal carbetocin for PWS misses primary endpoint
NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19
The FDA has cleared an IND for NeuroRx to conduct a clinical trial of an inhaled formulation of its RLF-100 aviptadil in patients with moderate or severe COVID-19, the company said. NeuroRx recently announced that an intravenous formulation of RLF-100 has shown promising results in patients with severe COVID-19 and that researchers in Brazil have demonstrated that … [Read more...] about NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19