According to Liquidia Corporation, United Therapeutics has filed a new patent infringement suit in the US District Court for the District of Delaware in response to Liquidia's submission of an sNDA for Yutrepia treprostinil DPI to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication. Yutrepia was tentatively approved … [Read more...] about United Therapeutics files new suit alleging that Liquidia’s Yutrepia treprostinil DPI infringes a patent covering Tyvaso
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ENA Respiratory announces new funding, personnel to support Phase 2b study of INNA-051 antiviral nasal spray
ENA Respiratory announced preparations for a Phase 2b study of its INNA-051 pegylated TLR2/6 agonist nasal spray for the prevention of respiratory viruses in people aged 65 and older will be supported by an additional $3.8 million from the US Department of Defense (DOD) as well as by several new clinical appointments. In January 2023, the company said that it had … [Read more...] about ENA Respiratory announces new funding, personnel to support Phase 2b study of INNA-051 antiviral nasal spray
Orexo gets US patent related to its OX640 intranasal dry powder epinephrine
According to Orexo, the United States Patent and Trademark Office (USPTO) has issued the company US patent No. 11,737,980 ("Pharmaceutical composition for drug delivery") which provides protection for OX640 epinephrine nasal powder. Orexo notes that it also received a European patent covering OX640 in 2022. The company announced Phase 1 results for OX640 in October … [Read more...] about Orexo gets US patent related to its OX640 intranasal dry powder epinephrine
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
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
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
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