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
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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
Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned
Gossamer Bio and Chiesi Farmaceutici have partnered to develop and commercialize Gossamer's seralutinib inhalation powder for the treatment of pulmonary hypertension, the companies announced. Chiesi, which will get 50% of US commercial profit and ex-US rights to seralutinib, will pay Gossamer $160 million for development reimbursement; up to $146 million in regulatory … [Read more...] about Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned
Iconovo’s ICOres DPI gets Chinese patent
According to Iconovo, the Chinese Patent Office has said it will approve the company's application for a patent covering its ICOres reservoir-based dry powder inhaler platform that will provide protection until 2040. The ICOres platform has already received patent protection in the US, Europe, Sweden, India, and Japan, the company said. The dual chamber ICOres … [Read more...] about Iconovo’s ICOres DPI gets Chinese patent
MannKind’s clofazimine inhalation suspension gets Fast Track designation
MannKind Corporation announced that its MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections has been granted Fast Track designation by the FDA. MNKD-101 had already received orphan drug and qualified infectious disease product (QIDP) designations. The FDA recently cleared MannKind's IND for the Phase 3 … [Read more...] about MannKind’s clofazimine inhalation suspension gets Fast Track designation
Bespak and H&T Presspart announce partnership on LGWP propellant transition services
Device and component maker H&T Presspart and CDMO Bespak, which recently spun out from Recipharm, have announced that they will collaborate on projects related to low global warming potential (LGWP) propellants. According to the companies, "The collaboration leverages H&T Presspart’s expertise in inhalation product development, the company’s low GWP filling … [Read more...] about Bespak and H&T Presspart announce partnership on LGWP propellant transition services
ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus
ARS Pharmaceuticals announced has submitted its Day 180 response regarding the company's MAA for Neffy epinephrine nasal spray to the EMA's Committee for Medicinal Products for Human Use (CHMP) and expects an opinion on the MAA by mid-2024. The company said that it received Day 180 comments in late 2023 requesting results from a repeat dose study of Neffy under nasal … [Read more...] about ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus