GH Research Ireland has closed a $125 million Series B financing round to fund development of its GH001 inhaled 5-MeO-DMT, the company announced. 5-MeO-DMT is psychedelic found in the venom of certain toads. GH is currently developing GH001 for the treatment of treatment resistant depression, and according to the announcement, "The company's goal is to administer … [Read more...] about GH Research raises $125 million for development of inhaled 5-MeO-DMT
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Pulmatrix regains rights to its inhaled narrow spectrum kinase inhibitors from J&J
Johnson & Johnson has decided not to exercise an option acquired in a 2020 agreement with Pulmatrix for development and commercialization of Pulmatrix's portfolio of inhaled narrow spectrum kinase inhibitors (NSKIs), including PUR1800. J&J's Lung Cancer Initiative had been interested in developing the dry powder formulation for lung cancer … [Read more...] about Pulmatrix regains rights to its inhaled narrow spectrum kinase inhibitors from J&J
AIM ImmunoTech says early results from Phase 1 safety study of intranasal Ampligen are positive
AIM ImmunoTech has announced that it will definitely advance an intranasal formulation of its Ampligen rintatolimod into a Phase 2 trial after the initial dose tested in a Phase 1 study showed no safety problems. The company announced initiation of the Phase 1 study, which is set to enroll 40 healthy subjects, in March 2021. The Phase 1 study began with a 75 μg dose … [Read more...] about AIM ImmunoTech says early results from Phase 1 safety study of intranasal Ampligen are positive
Teva’s Seffalair Spiromax and BroPair Spiromax approved in Europe
According to Teva Pharmaceuticals Europe, the company has received marketing authorization in the EU for duplicate DPIs Seffalair Spiromax salmeterol xinafoate/ fluticasone propionate and BroPair Spiromax salmeterol xinafoate/ fluticasone propionate for the treatment for asthma in patients aged 12 and older. The company said that the Spiromax device "has been well … [Read more...] about Teva’s Seffalair Spiromax and BroPair Spiromax approved in Europe
Intravacc announces results of pre-clinical study of its intranasal COVID-19 vaccine candidate
Intravacc has announced that a pre-clinical study of its intranasal outer membrane vesicle (OMV)-based recombinant spike protein (rSP) vaccine candidate against SARS-CoV-2 nose spray vaccine in hamsters and mice demonstrated complete protection. The company announced in June 2020 that it had partnered with Wageningen Bioveterinary Research and Utrecht University to … [Read more...] about Intravacc announces results of pre-clinical study of its intranasal COVID-19 vaccine candidate
Kindeva and Cambridge Healthcare Innovations partner on development of CHI’s Aeolus DPI
Kindeva Drug Delivery has partnered with Cambridge Healthcare Innovations (CHI) for development and commercialization of CHI’s Aeolus DPI platform, the company said. The Aeolus device is breath-activated, blister-based, and comes in single use, reusable, and multi-unit dose versions. As part of the collaboration, Kindeva will supply product development and regulatory … [Read more...] about Kindeva and Cambridge Healthcare Innovations partner on development of CHI’s Aeolus DPI
Seelos says it has signed an agreement to use Aptar Pharma’s BDS device for its intranasal ketamine
Seelos Therapeutics has signed a strategic device partnership agreement with Aptar Pharma for the use of Aptar's Bidose Liquid System (BDS) for Seelos' SLS-002 intranasal ketamine, Seelos said. SLS-002 is in Phase 2 development for the treatment of suicidal ideation in patients with major depressive disorder. The company noted that the agreement also includes the … [Read more...] about Seelos says it has signed an agreement to use Aptar Pharma’s BDS device for its intranasal ketamine
Phase 1 study of Union Therapeutics’ inhaled and intranasal niclosamide meets all endpoints
According to Union Therapeutics, a Phase 1 study of its UNI911 niclosamide solution met its primary endpoint, demonstrating "a strong safety profile" for both inhaled and intranasal delivery; the company said that the PK results were also encouraging. Union is developing the formulation for the prevention of COVID-19 (UNI91103) and for the treatment of COVID-19 … [Read more...] about Phase 1 study of Union Therapeutics’ inhaled and intranasal niclosamide meets all endpoints
Respirent submits ANDA for generic version of Advair Diskus
Respirent has submitted an ANDA to the FDA for its fluticasone propionate / salmeterol xinafoate DPI in 100/50 μg, 250/50 μg, and 500/50 μg dose levels for the treatment of asthma and COPD, according to Lannett, which acquired US rights to the generic version of Advair Diskus in October 2019. Lannett said that the term of that deal has recently been extended to 12 … [Read more...] about Respirent submits ANDA for generic version of Advair Diskus
FDA approves Tyvaso inhalation solution for the treatment of PH-ILD
According to United Therapeutics, the FDA has approved Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso has been approved for the treatment of pulmonary arterial hypertension since July 2009. United Therapeutics submitted the sNDA for the PH-ILD indication in August 2020, … [Read more...] about FDA approves Tyvaso inhalation solution for the treatment of PH-ILD