A number of Cambridge, UK-based companies with extensive experience in inhaler design and development have responded to a request from the UK government to join an initiative to rapidly increase the country's manufacture of ventilators in response to the COVID-19 pandemic. Companies joining the effort include Team Consulting, Cambridge Consultants, PA Consulting, … [Read more...] about Device development companies aid in UK ventilator effort
News
CHMP adopts positive opinion regarding Atectura Breezhaler and Bemrist Breezhaler
At a March 27, 2020 meeting of the EMA's Committee for Medicinal Products for Human Use (CHMP), the committee adopted a positive opinion regarding the MAAs for Novartis's Atectura Breezhaler indacaterol/mometasone furoate and a duplicate inhaler, Bemrist Breezhaler. Both will be available in 125 mcg/260 mcg, 125 mcg/127.5 mcg and 125 mcg/62.5 mcg strengths for the … [Read more...] about CHMP adopts positive opinion regarding Atectura Breezhaler and Bemrist Breezhaler
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
Lee’s provides funding for Phase 2b study of Windtree’s Aerosurf for RDS in premature infants
Windtree Therapeutics has announced that Lee's Pharmaceutical Holdings will provide funding for a Phase 2b study of Windtree's Aerosurf inhaled KL4 surfactant for the treatment of respiratory distress syndrome in preterm infants. Windtree will repay 125% of the funding to Lee's from revenues or other payments resulting from activities related to the KL4 … [Read more...] about Lee’s provides funding for Phase 2b study of Windtree’s Aerosurf for RDS in premature infants
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
Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients
Vero Biotech has announced that the FDA will allow expanded access to the company's Genosyl DS tankless inhaled nitric oxide (iNO) delivery system so that it can be used for the treatment of cardiopulmonary symptoms of COVID-19. According to Vero, the system can be used in either hospital or home settings. The FDA approved Genosyl iNO for the treatment of persistent … [Read more...] about Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients
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