Amphastar Pharmaceuticals announced that the FDA has approved the company's ANDA for a generic version of Teva's ProAir HFA albuterol MDI for the treatment of asthma and said that it plans to launch the inhaler in the 3rd quarter of 2024. Amphastar's currently marketed OINDPs include Baqsimi intranasal dry powder glucagon, Rextovy naloxone nasal spray, and Primatene … [Read more...] about FDA approves Amphastar’s ANDA for generic of ProAir HFA albuterol MDI
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Celon Pharma announces creation of Novohale Therapeutics in partnership with Tang Capital, Phase 3 development of Falkieri esketamine DPI
Celon Pharma has disclosed a deal in which it will invest $20 million over 2 years, and Tang Capital will invest $10 million over that same period, in a new US-based company called Novohale Therapeutics that will initiate Phase 3 development of Celon's Falkieri esketamine DPI for the treatment of bipolar depression. Celon's marketed products include the Salmex … [Read more...] about Celon Pharma announces creation of Novohale Therapeutics in partnership with Tang Capital, Phase 3 development of Falkieri esketamine DPI
Cleveland Clinic to perform additional preclinical testing of dry powder universal flu vaccine candidates formulated with TFF technology
TFF Pharmaceuticals announced the Cleveland Clinic Florida will perform additional preclinical studies of 3 dry powder hemagglutinin antigen/adjuvent vaccine candidates produced under a 2023 SBIR grant to TFF for preclinical development of a dry powder pan-influenza vaccine formulation for inhaled and/or nasal delivery. The vaccine developed in Ted Ross's lab at the … [Read more...] about Cleveland Clinic to perform additional preclinical testing of dry powder universal flu vaccine candidates formulated with TFF technology
Inimmune announces results from Phase 1b trial of INI-2004 intranasal TLR4 agonist
According to Inimmune, a Phase 1b trial of its INI-2004 TLR4 agonist in people with allergic rhinitis demonstrated dose dependent reduction of nasal congestion compared to placebo in a ragweed challenge test, with a reduction of 53% for the highest dose. The company also said that all doses were well tolerated, with no difference in adverse events between the INI-2004 … [Read more...] about Inimmune announces results from Phase 1b trial of INI-2004 intranasal TLR4 agonist
EVŌQ Bio says it had pre-IND meeting with the FDA for its EVQ-218 inhaled non-ionic silver nanoparticle
EVŌQ Bio said that it had positive feedback from the FDA following a pre-IND meeting about EVQ-218 inhaled non-ionic silver nanoparticle, which the company is developing for the treatment of pulmonary bacterial infections in cystic fibrosis patients with funding from the Cystic Fibrosis Foundation. According to parent company EVŌQ Nano's web site, an IND submission … [Read more...] about EVŌQ Bio says it had pre-IND meeting with the FDA for its EVQ-218 inhaled non-ionic silver nanoparticle
Iconovo announces plans for development of inhaled GLP-1 products for the treatment of obesity
DPI developers Iconovo have announced plans to develop inhaled GLP-1 receptor agonists for the treatment of obesity and, potentially, related metabolic diseases. The company says that it plans to conduct preclinical proof-of-concept studies itself and then will look to out-license the inhalers. As part of its efforts in this area, the company said that it had filed "a … [Read more...] about Iconovo announces plans for development of inhaled GLP-1 products for the treatment of obesity
Renaissance Lakewood opens new headquarters
CDMO Renaissance Lakewood, which offers a wide range of nasal spray development and manufacturing services, announced the official opening of its new offices and warehouse space in Lakewood, NJ, USA. According to the company, the new 81,000 sq ft headquarters includes 67,000 sq ft of warehouse space that is expected to be in use within the next few months. The space … [Read more...] about Renaissance Lakewood opens new headquarters
ENA Respiratory gets US patent covering INNA-051 intranasal antiviral
ENA Respiratory announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application titled “Novel molecules” (US 18/112091), which covers the company's INNA-051 intranasal TLR2/6 agonist. According to ENA, INNA-051 is now covered by 30 patents in the US, Europe, and other markets. The FDA recently cleared the … [Read more...] about ENA Respiratory gets US patent covering INNA-051 intranasal antiviral
Bespak and DevPro developing HFO-1234ze albuterol MDI
CDMO Bespak and DevPro Biopharma have revealed their partnership on development of DevPro's DP007 albuterol MDI, which is formulated with Honeywell's Solstice Air HFO-1234ze(E) propellant. According to the companies, DP007 is expected to provide a lower global warming potential alternative to Ventolin HFA MDI. Bespak and DevPro say that they plan to initiate clinical … [Read more...] about Bespak and DevPro developing HFO-1234ze albuterol MDI
Kindeva to add additional LGWP propellant MDI manufacturing line
Kindeva Drug Delivery has announced that it will install a second LGWP propellant MDI manufacturing line at its facility in Loughborough, UK. The company's first LGWP line at Loughborough is expected to be completed by the end of this year. Kindeva The new line, which will fill both HFA-152a and HFO-1234ze(e), is expected to come on line in 2026. In August 2023, … [Read more...] about Kindeva to add additional LGWP propellant MDI manufacturing line