PureIMS has announced that it intends to initiate a dose-finding study of its Levodopa Cyclops DPI titled "A pilot open-label, randomized, crossover, comparative bioavailability study of levodopa administered via Levodopa Cyclops (test product) relative to Inbrija (reference product) in healthy adult subjects" by the end of this year. In April 2023, PureIMS announced … [Read more...] about PureIMS announces planned Phase 1 trial of Levodopa Cyclops
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Immune Biosolutions reports results from Phase 1 and 2 trials of IBIO123 inhaled antibody therapy for COVID-19
Immune Biosolutions has announced the publication of results from Phase 1 and 2 trials of the company's IBIO123 inhaled antibody therapy in patients with COVID-19 in The Lancet Infectious Diseases. Immune Bio announced the initiation of the Phase 1 trial in October 2021. According to the journal article, the Phase 2 study was stopped early because COVID-19 became … [Read more...] about Immune Biosolutions reports results from Phase 1 and 2 trials of IBIO123 inhaled antibody therapy for COVID-19
Honeywell and Recipharm partner on development of MDIs using Solstice Air HFO-1234ze(e) propellant
Propellant manufacturer Honeywell and CDMO Recipharm are partnering on development of MDIs formulated with Honeywell’s Solstice Air lower-GWP propellant, the companies said. Honeywell announced in October 2022 that it had started large scale manufacturing of medical grade Solstice Air HFO-1234ze(e) for use in metered dose inhalers and has previously announced a … [Read more...] about Honeywell and Recipharm partner on development of MDIs using Solstice Air HFO-1234ze(e) propellant
FDA issues warning letter to AstraZeneca over efficacy claims for Breztri MDI
The FDA issued a warning letter to AstraZeneca dated August 4, 2023 that cites multiple "false or misleading claims and/or representations" about the efficacy of the company's Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI. Breztri was approved by the FDA for the treatment of COPD in July 2020. According to the warning letter, the … [Read more...] about FDA issues warning letter to AstraZeneca over efficacy claims for Breztri MDI
Lupin launches its generic tiotropium bromide DPI in the US
Lupin has launched its generic version of Spiriva HandiHaler tiotropium bromide DPI for the treatment of COPD in the US, the company said. The FDA approved Lupin's ANDA for the tiotropium bromide inhaler in June 2023. The generic of Spiriva HandiHaler was recently approved in Australia and has also been approved in the UK and Canada. Lupin CEO Vinita Gupta … [Read more...] about Lupin launches its generic tiotropium bromide DPI in the US
Impel Pharmaceuticals says that it may need to sell assets or enter bankruptcy
Trudhesa dihydroergotamine (DHE) nasal spray maker Impel Pharmaceuticals (formerly Impel Neuropharma) has filed a document with the US Securities and Exchange Commission stating that it "has concluded that there is substantial doubt about the Company’s ability to continue as a going concern." Earlier this year, Impel announced that it needed to "streamline" and would … [Read more...] about Impel Pharmaceuticals says that it may need to sell assets or enter bankruptcy
Galecto to discontinue development of its GB0139 DPI for the treatment of IPF after Phase 2b trial fails to meet its primary endpoint
Galecto has announced that the Phase 2b GALACTIC-1 of its GB0139 inhaled galectin-3 inhibitor for the treatment of idiopathic pulmonary fibrosis failed to meet its primary endpoint and, as a result, the company will discontinue development of the DPI. GALACTIC-1 was initiated in February 2019. In March 2021, Galecto announced that it was discontinuing the higher dose … [Read more...] about Galecto to discontinue development of its GB0139 DPI for the treatment of IPF after Phase 2b trial fails to meet its primary endpoint
FDA clears Tiziana’s IND for intranasal foralumab in Alzheimer’s disease
According to Tiziana Life Sciences, the FDA has cleared the company's IND to allow clinical development of intranasal foralumab in Alzheimer's disease. Earlier this year, Tiziana announced plans to develop foralumab, an intranasal anti-CD3 monoclonal antibody, for the treatment of Alzheimer's and Type 1 diabetes. The company is also developing intranasal foralumab for … [Read more...] about FDA clears Tiziana’s IND for intranasal foralumab in Alzheimer’s disease
SPH Sine to use Marinomed solubility enhancement technology for formulation of an OINDP
Marinomed Biotech has announced that its Solv4U unit is working with SPH Sine Pharmaceutical Laboratories to develop an OINDP formulation using Marinomed's Marinosolv solubility enhancement technology. According to Marinomed, a feasibility study has been completed, and the companies expect to jointly seek a patent for the Marinosolv formulation. The announcement does … [Read more...] about SPH Sine to use Marinomed solubility enhancement technology for formulation of an OINDP
Silo Pharma says it will develop intranasal formulation of SPC-15 ketamine for the treatment of stress disorders
Silo Pharma said that it is planning to develop an intranasal formulation of its SPC-15, which includes "ketamine compositions," for the prevention and treatment of stress disorders, including anxiety and PTSD. The formulation was developed at Columbia University under a sponsored research agreement. According to Silo, US Patent no 11,622,948 ("Biomarkers for Efficacy … [Read more...] about Silo Pharma says it will develop intranasal formulation of SPC-15 ketamine for the treatment of stress disorders