According to ARS Pharmaceuticals, the FDA has issued a complete response letter to the company's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis, and the agency has requested the completion of a PK/PD repeated-dose study prior to approval. The CRL also asked for more information on nitrosamine impurities, which the … [Read more...] about FDA issues CRL to ARS’ NDA for Neffy intranasal epinephrine for the treatment of allergic reactions
News
Virex gets almost A$500,000 grant for development of GlyXine inhaled antiviral
The Western Australian Future Health Research and Innovation Fund has awarded a A$499,241 Innovation Seed Fund grant to Virex Pharma for development of Glyxine, an inhaled antiviral nanoemulsion, for the treatment of respiratory syncytial virus. According to Virex, the grant will go toward testing of Glyxine in epithelial cells and in animal models of RSV at Wal-yan … [Read more...] about Virex gets almost A$500,000 grant for development of GlyXine inhaled antiviral
Virpax spins off Novvae Pharmaceuticals to develop AnQlar nasal spray
Virpax Pharmaceuticals announced that it has spun off a wholly-owned subsidiary called Novvae Pharmaceuticals that will develop Virpax's over-the-counter products, starting with AnQlar antiviral nasal spray. Virpax acquired North American rights to AnQlar, which contains a mucoadhesive polymer derived from chitosan, from Nanomerics in August 2020 and expanded the deal … [Read more...] about Virpax spins off Novvae Pharmaceuticals to develop AnQlar nasal spray
Orexo resubmits NDA for OX124 intranasal naloxone
Orexo announced that it has resubmitted an NDA for OX124 naloxone nasal powder for the reversal of opioid overdose. In February 2023, the company announced that it had submitted an NDA for OX124 and then in April announced that it would have to resubmit the application due to "unexpected technical issues with the equipment used for the secondary packaging process in … [Read more...] about Orexo resubmits NDA for OX124 intranasal naloxone
FDA issues final guidance on human factors principles for combination products
The FDA issued a document on September 8, 2023 titled "Application of Human Factors Engineering Principles for Combination Products: Questions and Answers," which is the final version of a draft guidance titled "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development" that was issued in 2016. According to the … [Read more...] about FDA issues final guidance on human factors principles for combination products
Evoke Pharma gets notice of allowance for new US patent covering Gimoti metoclopramide nasal spray
According to Evoke Pharma, the company has received a notice of allowance from the US Patent and Trademark Office (USPTO) for patent application No. 17/366,829 ("Nasal Formulations of Metoclopramide"). The patent will cover the composition of Evoke's Gimoti intranasal metoclopramide, which was approved by the FDA in June 2020 for the treatment of diabetic … [Read more...] about Evoke Pharma gets notice of allowance for new US patent covering Gimoti metoclopramide nasal spray
NurExone says that it held pre-IND meeting with the FDA regarding ExoPTEN intranasal therapy for spinal cord injuries
NurExone Biologic announced that the company has received feedback from the FDA following a pre-IND meeting regarding NurExone's ExoPTEN intranasal exosome therapy and now plans to submit an IND by the end of this year with the goal of initiating Phase 1/2 clinical trials in 2025. In July 2022, the company said that it had contracted with Polyrizon for development of … [Read more...] about NurExone says that it held pre-IND meeting with the FDA regarding ExoPTEN intranasal therapy for spinal cord injuries
Startup AlveoGene to develop inhaled gene therapies
Oxford Science Enterprises and Harrington Discovery Institute at University Hospitals, together with the University of Edinburgh’s Old College Capital venture investment fund, have created a startup called AlveoGene to develop inhaled gene therapies based on a lentivirus platform technology licensed from the UK Respiratory Gene Therapy Consortium (GTC). The new … [Read more...] about Startup AlveoGene to develop inhaled gene therapies
Renaissance Lakewood announces major spray lab expansion
US-based CDMO Renaissance Lakewood, which offers a wide range of services for nasal spray development and manufacturing, has announced a significant expansion of its laboratories in New Jersey, the company said. The expansion is part of a larger relocation and upgrade project initiated in 2021 and expected to be completed by early next year. According to Renaissance, … [Read more...] about Renaissance Lakewood announces major spray lab expansion
Copley Scientific launches new patient exhalation simulator for DPI development
Copley Scientific has announced the launch of its new Patient Exhalation Simulator (PES) for use in dry powder inhaler development. According to Copley, the PES simulates exhalation into a DPI prior to inhalation of the dose, a type of misuse that can significantly affect delivery of the full dose and which may occur with more than 20% of patients. The company … [Read more...] about Copley Scientific launches new patient exhalation simulator for DPI development