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
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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
Avalyn names Howard M. Lazarus as Chief Medical Officer
Avalyn Pharma, which is developing inhaled formulations of pirfenidone and nintedanib for the treatment of pulmonary fibrosis, has announced the appointment of former Altavant Sciences Chief Medical Officer Howard M. Lazarus as Chief Medical Officer. Lazarus's previous positions include Medical Expert/Executive Director in Clinical Development and Medical Affairs at … [Read more...] about Avalyn names Howard M. Lazarus as Chief Medical Officer
Vistagen says Phase 3 PALISADE-2 trial PH94B fasedienol nasal spray for SAD met primary endpoint
Vistagen has announced that the Phase 3 PALISADE-2 public speaking challenge trial of PH94B fasedienol nasal spray in subjects with social anxiety disorder met its primary and secondary endpoints. The company announced the initiation of PALISADE-2 in September 2021 and then paused the trial in mid-2022 after PALISADE-1 failed to meet its primary endpoint. The trial … [Read more...] about Vistagen says Phase 3 PALISADE-2 trial PH94B fasedienol nasal spray for SAD met primary endpoint
Kindeva gets UK public/private funding for lower-GWP MDI manufacturing
The UK’s Life Sciences Innovation Manufacturing Fund, which provides public/private investment to the life sciences industry, has awarded a grant to CDMO Kindeva Drug Delivery. According to a UK government press release, "The investment will create 40 full-time jobs and safeguard 218 existing full-time jobs across Kindeva’s sites in Clitheroe and Loughborough." … [Read more...] about Kindeva gets UK public/private funding for lower-GWP MDI manufacturing
Inimmune initiates Phase 1/1b trial of INI-2004 intranasal TLR4 agonist
Missoula, Montana-based Inimmune Corporation has announced the initiation of Phase 1/1b trial of its INI-2004 intranasal toll-like receptor 4 agonist, which the company is developing for the treatment of allergic rhinitis. According to the company, the Phase 1 SAD portion of the study, which is taking place in Australia, will enroll healthy volunteers and patients … [Read more...] about Inimmune initiates Phase 1/1b trial of INI-2004 intranasal TLR4 agonist
Viatris and Kindeva launch Breyna budesonide / formoterol fumarate MDI in the US
Viatris and Kindeva Drug Delivery have announced the launch of Breyna budesonide / formoterol fumarate MDI, a generic version of AstraZeneca's Symbicort, for the treatment of asthma in patients aged 6 and over and for the treatment of COPD. The FDA tentatively approved Breyna in March 2021 and issued a final approval in March 2022 amid patent litigation from … [Read more...] about Viatris and Kindeva launch Breyna budesonide / formoterol fumarate MDI in the US