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
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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
Krystal Biotech says that it will develop an inhaled formulation of its KB707 gene therapy for the treatment of solid tumors
Krystal Biotech announced that it will develop injectable and inhaled versions of its KB707 gene therapy for the treatment of malignant solid tumors, including metastatic cancer. The company said that it intends to amend an existing IND to add a clinical trial of the inhaled formulation by the end of the year, with the trial expected to begin by mid-2024. Krystal … [Read more...] about Krystal Biotech says that it will develop an inhaled formulation of its KB707 gene therapy for the treatment of solid tumors
Appeals court upholds previous rulings in United Therapeutics suit against Liquidia over Yutrepia
The Court of Appeals for the Federal Circuit has upheld rulings by the United States District Court for the District of Delaware in a patent infringement suit filed by United Therapeutics against Liquidia Corporation alleging that Liquidia's Yutrepia treprostinil DPI infringes patents covering Tyvaso inhaled treprostinil. The FDA tentatively approved Liquidia's NDA … [Read more...] about Appeals court upholds previous rulings in United Therapeutics suit against Liquidia over Yutrepia
Insilico Medicine says it intends to file IND for ISM001-055 inhalation solution for IPF
Insilico Medicine, which claims to be "a generative artificial intelligence (AI)-driven clinical-stage drug discovery company," said that it is "the first AI drug discovery company to venture into nebulized formulations" as the company plans to file an IND for its ISM001-055 inhalation solution for the treatment of idiopathic pulmonary fibrosis. According to the … [Read more...] about Insilico Medicine says it intends to file IND for ISM001-055 inhalation solution for IPF
Lupin launches Luforbec beclometasone / formoterol MDI in Germany
Lupin announced that its German subsidiary Hormosan Pharma has launched Luforbec beclometasone / formoterol MDI for the treatment of asthma and COPD in Germany. According to Lupin, the price of the MDI, which is a generic of Chiesi's Foster (Fostair), will be set at just over half the reference price. Luforbec has been available in the UK since 2021. Hormosan … [Read more...] about Lupin launches Luforbec beclometasone / formoterol MDI in Germany
Pharma Nordic gets rights to market Altamira’s Bentrio nasal spray in Norway
Altamira Therapeutics announced that Pharma Nordic will market and distribute Bentrio bentonite-based OTC nasal spray for protection against allergens in Norway as part of a deal that could potentially expand to include Sweden, Finland, and Denmark, "subject to meeting certain milestones." Pharma Nordic will begin selling Bentrio in Norway in 2024, the company … [Read more...] about Pharma Nordic gets rights to market Altamira’s Bentrio nasal spray in Norway
Advent gets $3 million grant for development of inhaled vitamin A palmitate for the prevention of BPD in newborns
Advent Therapeutics announced that the company has received a $3 million Small Business Innovation Research (SBIR) Phase 2B grant from the National Institutes of Health for continued development of the company's inhaled vitamin A (retinol) palmitate formulation for the prevention of bronchopulmonary dysplasia (BPD) in newborn infants. According to the company, the … [Read more...] about Advent gets $3 million grant for development of inhaled vitamin A palmitate for the prevention of BPD in newborns
Kindeva, H&T Presspart, and Chiesi sign deal for dose counters
H&T Presspart will expand cleanroom facilities and add a new production line to manufacture Kindeva Drug Delivery's dose counters and dose indicators for use in Chiesi MDIs, the companies have announced. According to the announcement, the dose counters will be used in Chiesi's new lower-GWP MDIs. H&T Presspart previously signed a licensing deal with 3M (now … [Read more...] about Kindeva, H&T Presspart, and Chiesi sign deal for dose counters