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
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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
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