Aerami Therapeutics said that it has initiated dosing in a Phase 1 clinical trial of its AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH). According to the study description on clinicaltrials.gov, the SAD/MAD trial is expected to enroll 78 healthy volunteers and is expected to evaluate doses of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg in … [Read more...] about Aerami initiates Phase 1 trial of AER-901 inhaled imatinib for PAH
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Copley Scientific joins UK Taskforce for Lung Health Industries Forum
Copley Scientific announced that it has joined the Industries Forum of the UK's Taskforce for Lung Health, and Copley personnel will share their expertise to help advance the taskforce's five-year plan "to improve the nation’s lung health and provide better care for people with lung disease." The company said, "As the world’s leading manufacturer and supplier of … [Read more...] about Copley Scientific joins UK Taskforce for Lung Health Industries Forum
Merxin partners with the University of Hertfordshire for research on SMIs
Generic inhalation device developer Merxin has announced a three-year partnership with the University of Hertfordshire to further research on "the generation of fine mist and particle aerosols from formulations for deep lung delivery." Merxin will sponsor doctoral work by UH PhD student Aurélien Martin under the supervision of Professor Darragh Murnane that will … [Read more...] about Merxin partners with the University of Hertfordshire for research on SMIs
Positive results from Phase 1 trial of Nasus Pharma’s intranasal dry powder epinephrine
Nasus Pharma said that a Phase 1 PK study of its FMXIN002 intranasal dry powder epinephrine demonstrated that FMXIN002 could produce a maximum plasma level comparable to that of epinephrine delivered via EpiPen and reached that level significantly faster than the injection. The open-label SAD study enrolled 12 volunteers and compared 1.6 and 3.2 mg doses of FMXIN002 … [Read more...] about Positive results from Phase 1 trial of Nasus Pharma’s intranasal dry powder epinephrine
SaNOtize announces Phase 3 study of its nitric oxide nasal spray for COVID-19, new drug submission
SaNOtize Research and Development said that it has gotten approval from Health Canada to move ahead with two Phase 3 trials of its nitric oxide nasal spray for the prevention and treatment of COVID-19. The company also said that it has submitted a new drug submission to the Canadian regulators under a special Health Canada program allowing for rolling review of … [Read more...] about SaNOtize announces Phase 3 study of its nitric oxide nasal spray for COVID-19, new drug submission
Cipla, Glenmark announce final approval for arformoterol tartrate inhalation solution
Cipla and Glenmark Pharmaceuticals have announced that they have received final approval from the FDA for generic versions of Sunovion's Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Cipla said that its product is available immediately. Glenmark noted that the approval is its first for a nebulized product and said that it will … [Read more...] about Cipla, Glenmark announce final approval for arformoterol tartrate inhalation solution
Teva launches generic version of Perforomist inhalation solution in the US
Teva Pharmaceuticals said that it has launched a generic version of Perforomist formoterol fumarate inhalation solution for the treatment of COPD in the US. Perforomist was approved by the FDA in 2007; Teva first submitted an ANDA for its generic inhalation solution in 2009; the Teva ANDA was tentatively approved in May 2020; and Mylan's covering Perforomist expired … [Read more...] about Teva launches generic version of Perforomist inhalation solution in the US
Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint
Theravance Biopharma said that a Phase 2 study of its inhaled nezulcitinib (TD-0903) pan-JAK inhibitor in hospitalized COVID-19 patients failed to meet its primary endpoint of respiratory failure free days at Day 28. The study did demonstrate some improvement in all-cause mortality, and in patients with C-reactive protein levels below 150 mg/L, nezulcitinib … [Read more...] about Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint
PARI Pharma names Stefan Seemann as its new President
PARI Pharma has named Stefan Seemann as its new President, effective July 1, 2021. Seeman will take over from Martin Knoch, who is retiring after more than 30 years at PARI Pharma, where he oversaw development of the company's eFlow nebulizer technology. Seeman, who joined PARI Pharma in 2000 after several years at Boehringer Inhgelheim, was most recently VP for eFlow … [Read more...] about PARI Pharma names Stefan Seemann as its new President
Valeo launches Enerzair Breezhaler and Atectura Breezhaler in Canada
Valeo Pharma has announced the launch of the Enerzair Breezhaler indacaterol / glycopyrronium / mometasone furoate and Atectura Breezhaler indacaterol / mometasone furoate DPIs in Canada. The company acquired Canadian rights to the two Novartis dry powder inhalers in March 2021. Enerzair (QVM149) and Atectura (QMF149) are also approved in Europe and in … [Read more...] about Valeo launches Enerzair Breezhaler and Atectura Breezhaler in Canada