Savara announced that the UK Medicines and Healthcare Products Regulatory Agency has awarded an Innovation Passport to molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The Innovation Passport provides entry into the agency's Innovative Licensing and … [Read more...] about Savara’s molgramostim gets Innovation Passport from the MHRA
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Esteve Pharmaceuticals launches Inbrija levodopa DPI in Germany
Acorda Therapeutics announced that Inbrija levodopa inhalation powder has been launched in Germany by Esteve Pharmaceuticals. The EMA approved Inbrija DPI for the treatment of OFF periods in Parkinson’s disease in 2019. Acorda said that Esteve will pay "a significant double-digit percent of the selling price" plus sales based milestone payments. In July 2021, … [Read more...] about Esteve Pharmaceuticals launches Inbrija levodopa DPI in Germany
Helicon Health to distribute Adherium’s Hailie inhalor sensor in the UK
Adherium has announced that Helicon Health, a spin out from the UCL Centre for Health Informatics and Multi Professional Education, will market Adherium's Hailie inhaler sensors and monitoring service in the UK. According to the Helicon website, the company does three things: 1) "Deliver technological innovations that enable the virtual delivery of healthcare"; 2) … [Read more...] about Helicon Health to distribute Adherium’s Hailie inhalor sensor in the UK
Oragenics says preclinical data support further development of its intranasal COVID-19 vaccine
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
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