CyanVac has announced the initiation of a Phase 2b clinical study of CVXGA intranasal COVID-19 vaccine shortly after the company announced results from its Phase 2a trial. The Phase 2b trial, which is expected to enroll 10,000 participants, is funded by the Biomedical Advanced Research and Development Authority (BARDA) and will be conducted by the BARDA clinical … [Read more...] about CyanVac initiates Phase 2b trial of CVXGA intranasal COVID-19 vaccine
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Bespak and OzUK extend their partnership on LGWP MDI development services
Expanding on a partnership established in 2023, and following the closure of Bespak's OINDP development facilities in North Carolina, CDMO Bespak and CRO OzUK say that they will now offer continuity of low global warming potential (LGWP) propellant development projects between the two companies, with projects started at OzUK facilities then transfering to Bespak for … [Read more...] about Bespak and OzUK extend their partnership on LGWP MDI development services
Tiziana announces expansion of Phase 2 trial of intranasal foralumab for SPMS
Tiziana Life Sciences announced that a Phase 2a clinical of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS) has been expanded to include additional trial sites at Yale, Johns Hopkins, Cornell, Thomas Jefferson University, SUNY Buffalo, and UMass. The trial was initiated at the end of 2023 at Brigham and Women's … [Read more...] about Tiziana announces expansion of Phase 2 trial of intranasal foralumab for SPMS
MHRA grants Innovation Passport designation to Iliad’s BPZE1 intranasal pertussis vaccine
According to Iliad Biotechnologies, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) has granted Innovation Passport designation to Iliad's BPZE1 intranasal pertussis vaccine. BPZE1, which is in Phase 2 development, has previously received Fast Track designation from the FDA. The company notes that Phase 2b trials of BPZE1 in both adults and … [Read more...] about MHRA grants Innovation Passport designation to Iliad’s BPZE1 intranasal pertussis vaccine
Orbia announces planned expansion of HFA 152a manufacturing capacity
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
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