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
Regulatory
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Human Factors Engineering Principles for Combination Products: Questions and Answers," which is the final version of a draft guidance titled "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development" that was issued in 2016.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
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
FDA accepts Verona’s NDA for nebulized ensifentrine for the treatment of COPD
According to Verona Pharma, the FDA has accepted the company's NDA for its nebulized ensifentrine (RPL554) for the treatment of COPD with a PDUFA target date of June 26, 2024. The company submitted the NDA for ensifentrine, a PDE3/PDE4 inhibitor, at the end of June 2023. Verona is also developing DPI and MDI formulations of ensifentrine. Verona … [Read more...] about FDA accepts Verona’s NDA for nebulized ensifentrine for the treatment of COPD
United Therapeutics files new suit alleging that Liquidia’s Yutrepia treprostinil DPI infringes a patent covering Tyvaso
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
Krystal Biotech gets orphan drug designation for KB408 inhaled gene therapy for AAT deficiency
According to Krystal Biotech, the FDA has granted orphan drug designation to the company's KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin (AAT) deficiency. Krystal, which is also developing inhaled gene therapies for the treatment of cystic fibrosis (KB407) and solid tumors (KB707), says that KB408 is intended to deliver 2 copies of the … [Read more...] about Krystal Biotech gets orphan drug designation for KB408 inhaled gene therapy for AAT deficiency
FDA issues warning letter to AstraZeneca over efficacy claims for Breztri MDI
The FDA issued a warning letter to AstraZeneca dated August 4, 2023 that cites multiple "false or misleading claims and/or representations" about the efficacy of the company's Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI. Breztri was approved by the FDA for the treatment of COPD in July 2020. According to the warning letter, the … [Read more...] about FDA issues warning letter to AstraZeneca over efficacy claims for Breztri MDI
FDA clears Tiziana’s IND for intranasal foralumab in Alzheimer’s disease
According to Tiziana Life Sciences, the FDA has cleared the company's IND to allow clinical development of intranasal foralumab in Alzheimer's disease. Earlier this year, Tiziana announced plans to develop foralumab, an intranasal anti-CD3 monoclonal antibody, for the treatment of Alzheimer's and Type 1 diabetes. The company is also developing intranasal foralumab for … [Read more...] about FDA clears Tiziana’s IND for intranasal foralumab in Alzheimer’s disease
Marinomed’s Carragelose nasal spray gets marketing authorization in Mexico
Marinomed Biotech said that its partner M8 Pharmaceuticals has received marketing authorization for Carragelose iota-carrageenan nasal spray in Mexico. M8 acquired the rights to market the nasal spray in Mexico and Brazil in 2021. According to the announcement, the product will be marketed in Mexico as "Barlo," with a launch "envisaged for the next season." … [Read more...] about Marinomed’s Carragelose nasal spray gets marketing authorization in Mexico
Defender Pharmaceuticals submits NDA for DPI-386 scopolamine nasal gel for the prevention of motion sickness
Defender Pharmaceuticals announced that it has submitted an NDA for its DPI-386 scopolamine nasal gel for the prevention of motion sickness in adults. According to the company's web site, Defender has worked with the US Navy and with the National Aeronautics and Space Administration (NASA) on development of DPI-386. Epiomed Therapeutics, which was founded by … [Read more...] about Defender Pharmaceuticals submits NDA for DPI-386 scopolamine nasal gel for the prevention of motion sickness