Intranasal drug developer Orexo and Swedish vaccine developer Abera Bioscience have announced that they will collaborate on development of intranasal dry powder vaccines based on Orexo's AmorphOX powder engineering technology and Abera's vaccine platform, starting with an influenza vaccine. Abera will fund the project using grant money it has received from the … [Read more...] about Orexo and Abera partner on development of intranasal dry powder vaccines
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ARS says regulatory submissions for neffy epinephrine nasal spray have been filed in China, Japan, and Australia
ARS Pharmaceuticals has announced that its partners in China, Japan, and Australia have all submitted marketing applications for approval of neffy epinephrine nasal spray for the treatment of serious allergic reactions in their respective countries. ARS is partnered with Pediatrix Therapeutics in China; with Alfresa Pharma in Japan; and with CSL Seqirus in Australia … [Read more...] about ARS says regulatory submissions for neffy epinephrine nasal spray have been filed in China, Japan, and Australia
MannKind’s Afrezza insulin DPI approved in India for the treatment of diabetes
According to MannKind Corporation, the Indian Central Drugs Standard Control Organization (CDSCO) has approved a marketing application submitted by Cipla for Afrezza inhaled dry powder insulin for the treatment of diabetes in adults. Cipla acquired the rights to market Afrezza in India in a deal signed in 2018. Afrezza has been approved in the US since 2014 and … [Read more...] about MannKind’s Afrezza insulin DPI approved in India for the treatment of diabetes
Merxin and OECHSLERhealth partner on SMI development services
Merxin Ltd and contract device manufacturer OECHSLERhealth have announced the formation of a strategic partnership called The SMI PowerHouse for manufacturing of Merxin's MRX004 soft mist inhaler, a generic version of the Respimat device. According to the announcement, the two companies have worked together since 2018. Merxin and OECHSLERhealth say that the … [Read more...] about Merxin and OECHSLERhealth partner on SMI development services
Intertek and CrystecPharma partner on DPI development services
Intertek, which provides a wide range of testing services for OINDPs, has announced a new partnership with particle engineering specialist CrystecPharma for creation of a "fast to clinic" development platform for dry powder inhaler formulations. The company says that as of January 2025, the new platform will halve the time typically required to develop DPI … [Read more...] about Intertek and CrystecPharma partner on DPI development services
Qnovia raises $16 million for continued development of QN-01 inhaled nicotine for smoking cessation
Qnovia announced that it has raised $16 million in Series B financing for development of its QN-01 nicotine inhaler for smoking cessation in the UK. In the US, the FDA recently approved Qnovia's IND for a new Phase 1 study of QN-01, which is delivered via a device based on the company's RespiRx vibrating mesh nebulizer technology. According to the announcement, … [Read more...] about Qnovia raises $16 million for continued development of QN-01 inhaled nicotine for smoking cessation
CyanVac initiates Phase 2b trial of CVXGA intranasal COVID-19 vaccine
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
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