Altimmune has discontinued development of its AdCOVID intranasal vaccine for the prevention of COVID-19 after the failure of a Phase 1 trial and has stopped enrollment in a Phase 1/2 trial of its T-COVID intranasal therapy for COVID-19 the company said. The FDA had cleared the IND for the Phase 1 trial of AdCOVID in February 2021; the Phase 1/2 trial of T-COVID was … [Read more...] about Altimmune halts development of AdCOVID intranasal vaccine, terminates trial of T-COVID intranasal therapeutic
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Ampio initiates Phase 2 trial of inhaled Ampion in COVID-19 patients
Ampio Pharmaceuticals has announced the initiation of the AP-019 Phase 2 clinical trial of inhaled Ampion for the treatment of respiratory distress in patients with COVID-19. The company said that it has also received the okay from the FDA to add at least one trial site in India which currently has a high incidence of COVID-19; the initial location was in the US. … [Read more...] about Ampio initiates Phase 2 trial of inhaled Ampion in COVID-19 patients
Pieris announces development of inhaled anticalin for IPF, long COVID
Pieris Pharmaceuticals has announced that it will develop an inhaled anticalin known as PRS-220 for the treatment of idiopathic pulmonary fibrosis and for pulmonary fibrosis following COVID infection, with both programs slated to start in 2022. A €14.2 million grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy will fund development … [Read more...] about Pieris announces development of inhaled anticalin for IPF, long COVID
UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims
According to Starpharma, LloydsPharmacy has paused sales of Starpharma's Viraleze astodrimer sodium antiviral nasal spray after the UK Medicines and Healthcare products Regulatory Agency (MHRA) questioned "promotional claims, including references to SARS-CoV-2 and COVID-19, and the interrelationship between these product claims and its categorization." The company … [Read more...] about UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims
Aerami initiates Phase 1 trial of AER-901 inhaled imatinib for PAH
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
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