Bryn Pharma announced the publication of a poster presenting data from a Phase 1 PK/PD study of its BRYN-NDS1C intranasal epinephrine, which is delivered via an Aptar Pharma Bidose nasal device. In October 2019, Bryn announced that it had raised $17.5 million for development of BRYN-NDS1C, which has received Fast Track designation from the FDA. The study, which … [Read more...] about Bryn Pharma presents data from Phase 1 study of its intranasal epinephrine
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UW–Madison, FluGen, and Bharat Biotech partner to develop intranasal COVID-19 vaccine
The University of Wisconsin–Madison has announced that virologists from the university have partnered with vaccine companies FluGen and Bharat Biotech on development of an intranasal vaccine against unique vaccine against SARS-CoV-2 for the prevention of COVID-19. FluGen, a UW spin off co-founded by faculty member Yoshihiro Kawaoka, will create the vaccine and … [Read more...] about UW–Madison, FluGen, and Bharat Biotech partner to develop intranasal COVID-19 vaccine
Neurimmune and Ethris partner on development of inhaled mRNA-based antibody therapy for COVID-19
Swiss biotech Neurimmune has partnered with German mRNA specialist Ethris to develop inhaled mRNA-encoded neutralizing anti-SARS-CoV-2 antibodies for the treatment of Covid-19, the companies said. The goal is to begin clinical manufacturing of the drug this summer and initiate clinical trials in the fourth quarter of this year. The proposed COVID-19 therapy would … [Read more...] about Neurimmune and Ethris partner on development of inhaled mRNA-based antibody therapy for COVID-19
APEPTICO signs grant agreement with EC to accelerate availability of inhaled solnatide for COVID-19
Austrian biotech APEPTICO said that it has signed a grant agreement with the European Commission to accelerate the availability of the company's solnatide (AP301), an inhaled peptide, available for treatment of patients with severe COVID-19. APEPTICO had been invited to apply for a grant through the Horizon 2020 “Advancing knowledge for the clinical and public health … [Read more...] about APEPTICO signs grant agreement with EC to accelerate availability of inhaled solnatide for COVID-19
Altimmune and UAB partner to develop intranasal COVID-19 vaccine
Altimmune has announced a collaboration with the University of Alabama at Birmingham (UAB) for development of an intranasal COVID-19 vaccine. Six laboratories at UAB are expected to work on the single dose vaccine, called AdCOVID, to complete immunogenicity and pre-clinical studies with the goal of initiating a Phase 1 clinical trial in the third quarter of 2020. In … [Read more...] about Altimmune and UAB partner to develop intranasal COVID-19 vaccine
Positive Phase 2 results for Verona’s ensifentrine MDI
Verona Pharma has announced that a Phase 2 trial of 5 dosage strengths of an MDI formulation of ensifentrine for the treatment of moderate to severe COPD demonstrated that all but the lowest dose of ensifentrine produced statistically significant and clinically meaningful improvement in lung function compared to placebo. The 40 COPD patients enrolled in the trial each … [Read more...] about Positive Phase 2 results for Verona’s ensifentrine MDI
Savara halts trials of Molgradex and Aerovanc due to COVID-19 pandemic
Savara announced that it has halted two studies: the Phase 2a ENCORE study of Molgradex inhaled human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infections in cystic fibrosis patients and the Phase 3 AVAIL studies of AeroVanc vancomycin DPI for the treatment of MRSA lung infections in cystic … [Read more...] about Savara halts trials of Molgradex and Aerovanc due to COVID-19 pandemic
Patient advocacy group expresses support for FDA approval of Savara’s Molgradex inhaled GM-CSF
The PAP Foundation, a US organization that advocates for pulmonary alveolar proteinosis (PAP) patients, says that it supports FDA approval of Savara's Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The group said that it expressed this opinion at the FDA's Rare Disease Day in February 2020 and is officially submitting … [Read more...] about Patient advocacy group expresses support for FDA approval of Savara’s Molgradex inhaled GM-CSF
Phase 3 trial of Milestone’s etripamil nasal spray for PSVT misses primary endpoint
Milestone Pharmaceuticals has reported that the Phase 3 NODE-301 trial of its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) has missed its primary endpoint of time to conversion of SVT to sinus rhythm compared to placebo over the five hours post dose. The NODE-301 trial, which was initiated in August 2018, enrolled 431 … [Read more...] about Phase 3 trial of Milestone’s etripamil nasal spray for PSVT misses primary endpoint
Windtree Therapeutics to study its KL4 surfactant for COVID-19
Windtree Therapeutics has announced that it plans to study its KL4 surfactant for the treatment of acute respiratory distress syndrome (ARDS) in patients suffering from COVID-19. Windtree's Aerosurf -- KL4 delivered via the company's proprietary Aerosol Delivery System (ADS) -- is in development for the treatment of respiratory distress syndrome (RDS) in premature … [Read more...] about Windtree Therapeutics to study its KL4 surfactant for COVID-19