Orbia Fluor & Energy Materials (formerly Koura Global) has announced plans for a new manufacturing facility for its Zephex HFA 152a LGWP MDI propellant, saying that the plant will produce significantly more 152a than the first plant that was opened in 2022. The announcement does not specify the size of the increase in capacity or the size of the investment. The … [Read more...] about Orbia announces planned expansion of HFA 152a manufacturing capacity
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Hovione completes expansion of spray drying facilities in US and Ireland
CDMO Hovione has announced the completion of expansion projects at its facilities in East Windsor, NJ, USA and Ringaskiddy, Cork, Ireland that its says will provide a significant increase in the company's spray drying capacity and will create more than 40 jobs. In November 2021, Hovione said that it was launching a $170 million project to increase capacity at its US, … [Read more...] about Hovione completes expansion of spray drying facilities in US and Ireland
FDA accepts Satsuma’s resubmitted NDA for STS101 intranasal dry powder DHE for the treatment of migraine
According to Satsuma Pharmaceuticals and its parent company Shin Nippon Biomedical Laboratories, the FDA has accepted the company's resubmitted NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine and has set a PDUFA date of April 30, 2025. Satsuma submitted the now-accepted NDA in October 2024. In March 2023, Satsuma submitted the original … [Read more...] about FDA accepts Satsuma’s resubmitted NDA for STS101 intranasal dry powder DHE for the treatment of migraine
Blue Lake and CyanVac report data from Phase 2a trial of CVXGA intranasal COVID-19 vaccine
Blue Lake Biotechnology and CyanVac reported that a Phase 2a clinical trial of their CVXGA intranasal vaccine against SARS-CoV-2 demonstrated that participants who received CVXGA had a 78% lower risk of symptomatic infection one month post vaccination compared to those who got a placebo. The study enrolled 227 participants. In addition, the companies said that no … [Read more...] about Blue Lake and CyanVac report data from Phase 2a trial of CVXGA intranasal COVID-19 vaccine
Virpax announces extension of NCATS R&D agreement for NES intranasal enkephalin
Virpax Pharmaceuticals announced the extension of a research and development agreement with an institute of the National Institutes of Health (NIH) related to the company's NES100 enkephalin nasal spray for the treatment of acute and chronic pain. NES100 is based on molecular envelope technology (MET) licensed from Nanomerics for delivery across the blood-brain … [Read more...] about Virpax announces extension of NCATS R&D agreement for NES intranasal enkephalin
Tiziana receives ALS Association grant to fund trial of intranasal foralumab in patients with ALS
The ALS Association, which supports research on amyotrophic lateral sclerosis, has awarded a grant to Tiziana Life Sciences to support a clinical trial of intranasal foralumab in 20 patients with ALS at Massachusetts General Hospital, Tiziana said. The amount of the award was not disclosed. According to Tiziana, the trial will use PET imaging to evaluate the … [Read more...] about Tiziana receives ALS Association grant to fund trial of intranasal foralumab in patients with ALS
Nocion initiates Phase 2b trial of NOC-110 taplucainium DPI for the treatment of chronic cough
Nocion Therapeutics has announced the initiation of the Phase 2b ASPIRE clinical trial of its NOC-110 inhaled dry powder taplucainium (formerly NTX-1175) in patients with chronic cough. Earlier this year, the company said that it had raised $62 million to conduct the trial, which is expected to enroll approximately 325 patients and will evaluate two dose levels of … [Read more...] about Nocion initiates Phase 2b trial of NOC-110 taplucainium DPI for the treatment of chronic cough
NurExone’s ExoPTEN intranasal exosome therapy for spinal cord injuries get orphan designation from the EMA
NurExone Biologic announced that the EMA has granted orphan medicinal product designation to NurExone's ExoPTEN intranasal exosome therapy, which the company is developing for the treatment of spinal cord injury. In 2023, the FDA granted orphan drug designation to ExoPTEN, and the company held a pre-IND meeting with the agency in anticipation of beginning clinical … [Read more...] about NurExone’s ExoPTEN intranasal exosome therapy for spinal cord injuries get orphan designation from the EMA
AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
UK-based start-up AlveoGene announced that its AVG-002 nebulized gene therapy for neonatal surfactant protein B (SP-B) deficiency has received a rare pediatric disease designation from the FDA. The company says that it will advance AVG-002 into clinical development and could submit a marketing application as soon as 2028. According to Alveogene, studies in SP-B … [Read more...] about AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
Pulmatrix agrees to merge with Cullgen and will divest inhalation assets
Pulmatrix has announced a planned merger with biopharma Cullgen, which is developing oral protein degraders for the treatment of various indications. In anticipation of the merger, Pulmatrix says that it will divest inhalation assets, including PUR1800 inhaled dry powder narrow spectrum kinase inhibitor, PUR3100 inhaled dry powder DHE, and patents related to the … [Read more...] about Pulmatrix agrees to merge with Cullgen and will divest inhalation assets