Inhaled drug developer Senzer has announced major changes to its management "aimed at bolstering its commercialization strategy for COVID-19 and cannabinoid treatments." In May 2020, Senzer announced that it was developing two inhaled anti-virals delivered via MDI for the treatment of COVID-19 in addition to the cannabinoids it is developing based on its Systemic … [Read more...] about Senzer announces management changes, including new Chairman and CEO
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Breztri Aerosphere triple combination MDI outperforms dual combination therapies in Phase 3 trial
AstraZeneca said that complete results from the Phase 3 ETHOS trial of its Breztri Aerosphere (PT010) budesonide/glycopyrronium/formoterol fumarate MDI demonstrated that the triple combination reduced moderate or severe COPD exacerbations by 24% compared to glycopyrronium/formoterol fumarate and by 13% compared to budesonide/formoterol fumarate. Patients using … [Read more...] about Breztri Aerosphere triple combination MDI outperforms dual combination therapies in Phase 3 trial
EverInsight Therapeutics gets Asian rights to VistaGen’s PH94B nasal spray
VistaGen Therapeutics has announced that it signed a deal giving EverInsight Therapeutics development and commercialization rights to Vistagen's PH94B aloradine nasal spray for anxiety disorders in China, South Korea, and a number of other Asian countries. EverInsight, funded by the CBC Group, is paying $5 million up front, plus a potential $172 million in milestone … [Read more...] about EverInsight Therapeutics gets Asian rights to VistaGen’s PH94B nasal spray
Gilead announces Phase 1 trial of inhaled remdesivir
Gilead Sciences Chairman and CEO Daniel O'Day has announced that the company has received FDA approval for a Phase 1 trial of inhaled remdesivir and will initiate the study within a week. Trials of the inhaled antiviral formulation in COVID-19 patients are expected to begin in August 2020. O'Day said, "Remdesivir, our investigational antiviral medicine, is … [Read more...] about Gilead announces Phase 1 trial of inhaled remdesivir
Preclinical study demonstrates potential of IntraVacc intranasal pertussis vaccine
Vaccine developer Intravacc has published data from a preclinical study of an intranasal whooping cough vaccine demonstrating strong immune responses in mice. The intranasal vaccine also prevented colonization of the lung, trachea, and nose by B. pertussis, the bacteria that causes whooping cough, while mice vaccinated by subcutaneous injection did experience nasal … [Read more...] about Preclinical study demonstrates potential of IntraVacc intranasal pertussis vaccine
Inhalation Sciences announces new agreement for project using DissolvIt lung simulation tool
Inhalation Sciences (ISAB) has announced that a "noted global pharma company" has placed an order worth €75,000 for a contract research project utilizing ISAB's DissolvIt system. The DissolvIt module is used to simulate dissolution and absorption of dry powder formulations in the lung and generates data including Cmax and Tmax curves. ISAB CEO Manoush Masarrat … [Read more...] about Inhalation Sciences announces new agreement for project using DissolvIt lung simulation tool
Gimoti metoclopramide nasal spray approved by the FDA
The FDA has approved Evoke Pharma's Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, the company said. Evoke originally submitted an NDA for Gimoti in in June 2018 and acknowledged receipt of a complete response letter to that NDA in April 2019. The company resubmitted the NDA in December 2019. In January 2020, Evoke announced that it … [Read more...] about Gimoti metoclopramide nasal spray approved by the FDA
TFF gets orphan drug designation for inhaled tacrolimus for prevention of lung transplant rejection
DPI developer TFF Pharmaceuticals said that the FDA has granted orphan drug designation to its dry powder tacrolimus for the prevention of lung transplant rejection. The company also said that it plans to initiate a Phase 1 SAD study of the tracrolimus inhalation powder this month followed by a MAD study in the third quarter of this year. TFF President and CEO … [Read more...] about TFF gets orphan drug designation for inhaled tacrolimus for prevention of lung transplant rejection
Renovion raises $8.1 million for development of inhaled mucolytic
North Carolina-based Renovion said that it has raised $8.1 million in a Series A financing round for development of its ARINA-1 nebulized glutathione/bicarbonate/ascorbic acid formulation for the treatment of chronic lung diseases. ARINA-1, which is delivered via the PARI eFlow nebulizer system, has been granted orphan drug designation by the FDA for the treatment of … [Read more...] about Renovion raises $8.1 million for development of inhaled mucolytic
Tonix Pharmaceuticals acquires intranasal oxytocin from Trigemina
Tonix Pharmaceuticals has announced that it will acquire assets from Trigemina, Inc that include intranasal oxytocin for the treatment of migraine headaches. Trigemina had licensed the nasal spray, now called TNX-1900, from Stanford University, and Tonix will assume that license. Trigemina Chief Medical Officer Shashidar H. Kori said, “We are excited that Tonix … [Read more...] about Tonix Pharmaceuticals acquires intranasal oxytocin from Trigemina