Oragenics has published data from studies of its NT-CoV-2-1 proteosome adjuvanted intranasal vaccine candidate against SARS-CoV-2 in mice and hamsters that support further development of the vaccine, the company said. The data were published June 13, 2022 in an article in Nature's Scientific Reports titled "Intranasal Immunization with a Proteosome-Adjuvanted … [Read more...] about Oragenics says preclinical data support further development of its intranasal COVID-19 vaccine
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Phase 3 ReOpen2 trial of Optinose’s Xhance intranasal fluticasone meets primary endpoints
Optinose has announced that the Phase 3 ReOpen2 trial of Xhance fluticasone propionate nasal spray (OPN-375) in patients with chronic sinusitis without nasal polyps demonstrated significant improvement compared to placebo in both patient reported symptoms at week 4 and inflammation measured by CT scan at week 24. The FDA approved Xhance in 2017 for the treatment of … [Read more...] about Phase 3 ReOpen2 trial of Optinose’s Xhance intranasal fluticasone meets primary endpoints
CounterAct naloxone nasal spray cap gets Canadian patent
According to CounterAct, the Canadian Intellectual Property Office has issued a patent (3065307, "Prescription bottle cap capable of administering opioid overdose reversal agent") covering the company's naloxone nasal spray cap. CounterAct co-founder Todd Pizitz commented, "We are pleased to continue to add to our intellectual property protection with the addition of … [Read more...] about CounterAct naloxone nasal spray cap gets Canadian patent
Opiant invests €2 million for expanded production of Aptar nasal device for use with OPNT003
Opiant Pharmaceuticals announced that it has signed an agreement with Aptar Pharma for expanded production of Aptar’s Unidose device in order to support potential commercial demand for Opiant's OPNT003 intranasal nalmefene. The agreement includes €2 million from Opiant for installation of the necessary production equipment. Opiant recently initiated a rolling NDA … [Read more...] about Opiant invests €2 million for expanded production of Aptar nasal device for use with OPNT003
Tiziana reports positive results for intranasal foralumab in second MS patient
Tiziana Life Sciences has announced that a second multiple sclerosis patient who received the company's intranasal foralumab for three months as part of an expanded access program at Brigham and Women’s Hospital (BWH) has showed significant improvement. According to Tiziana, PET imaging demonstrated inhibition of microglial activation, and the patient also showed … [Read more...] about Tiziana reports positive results for intranasal foralumab in second MS patient
RxPack joins IPAC-RS as associate member
Device company RxPack has joined the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) as an associate member, the company said. RxPack is a joint venture between Lindal Group and Coster Group that was formed in 2021 to distribute metered dose inhaler and nasal spray devices as well as Coster's aerosol filling … [Read more...] about RxPack joins IPAC-RS as associate member
BiondVax announces development plans for inhaled NanoAb for COVID-19
Following an advice meeting with the Paul Erhlich Institute, Israeli biopharm company BiondVax Pharmaceuticals announced plans for development of its lead candidate, an inhaled COVID-19 nanosized antibody (NanoAb) therapy. The company said that it hopes to initiate a Phase 1/2a clinical trial of the inhaled NanoAb in COVID-19 patients in 2023, following completion of … [Read more...] about BiondVax announces development plans for inhaled NanoAb for COVID-19
Opiant begins rolling NDA submission for OPNT003 intranasal nalmefene
Opiant Pharmaceuticals said that it has filed the first part of a 505(b)(2) NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose and that it expects to complete the submission later this year. The company recently announced that a PD study of OPNT003 met its primary endpoint. Opiant President and CEO Roger Crystal commented, "The opioid … [Read more...] about Opiant begins rolling NDA submission for OPNT003 intranasal nalmefene
FDA clears IND for Codagenix intranasal RSV vaccine
According to Codagenix, the FDA has cleared the company's IND for CodaVax-RSV intranasal live-attenuated vaccine (LAIV) for the prevention of respiratory syncytial virus (RSV) infection, and plans are in progress for a Phase 1 study in children aged 6 months to 5 years. Codagenix previously conducted a Phase 1 study of CodaVax-RSV in adults aged … [Read more...] about FDA clears IND for Codagenix intranasal RSV vaccine
FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI
According to Avillion, the FDA has accepted the company's NDA for AstraZeneca's PT027 albuterol/budesonide MDI for the treatment of asthma in patients aged 4 and older for review. In March 2018, Avillion announced that it was partnering with Pearl Therapeutics on development of PT027; Pearl was acquired by AstraZeneca in 2013. AstraZeneca has an option to … [Read more...] about FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI