Orion Pharmaceuticals has announced plans for a €30 million expansion of its production facility in Espoo, Finland, including a new filling line for its Easyhaler dry powder inhalers. The company said that it is responding to a projected increase in demand due to the perception by healthcare providers that DPIs are more sustainable than MDIs. Orion expects the project … [Read more...] about Orion to add DPI filling line to increase Easyhaler production capacity
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TFF gets almost $3 million from NIAID for development of dry powder universal flu vaccine
According to TFF Pharmaceuticals, the company has received a 3-year Direct to Phase 2 Small Business Innovation Research (SBIR) grant worth ~$2.97 million from the National Institute of Allergy and Infectious Diseases (NIAID) for further pre-clinical development of a dry powder pan-influenza vaccine formulation based on the company's thin film freezing technology. The … [Read more...] about TFF gets almost $3 million from NIAID for development of dry powder universal flu vaccine
Cystetic initiates Phase 1 trial of CM001 “molecular prosthetic” DPI
US-based start-up Cystetic Medicines has announced the initiation of a Phase 1 SAD/MAD trial of its CM001 dry powder "molecular prosthetic" in healthy volunteers. The company is developing CM001 for the treatment of cystic fibrosis and said that it plans to evaluate the DPI in CF patients later this year. CM001 is based on technology developed by Martin Burke of the … [Read more...] about Cystetic initiates Phase 1 trial of CM001 “molecular prosthetic” DPI
Tonix Pharmaceuticals acquires Tosymra intranasal sumatriptan
Tonix Pharmaceuticals announced that it will acquire the US rights to Tosymra sumatriptan nasal spray from Upsher-Smith along with Zembrace SymTouch sumatriptan injection, both for the treatment of migraines. Dr. Reddy's subsidiary Promius Pharma submitted an NDA for Tosymra in April 2018, and the FDA approved the product in January 2019. Upsher-Smith acquired the US … [Read more...] about Tonix Pharmaceuticals acquires Tosymra intranasal sumatriptan
Virpax announces that NIH group will conduct preclinical studies of NobrXiol intranasal CBD for the treatment of epilepsy
Virpax Pharmaceuticals said that it has signed a cooperative research and development agreement (CRADA) for evaluation of the company's NobrXiol (VRP324) cannabidiol nasal powder in rodent models of epilepsy and seizures by the Epilepsy Therapy Screening Program (ETSP) of the National Institute of Neurological Disorders and Stroke, part of the National Institutes of … [Read more...] about Virpax announces that NIH group will conduct preclinical studies of NobrXiol intranasal CBD for the treatment of epilepsy
MannKind initiates Phase 4 INHALE-3 trial of Afrezza inhaled insulin
MannKind Corporation has announced the initiation of the Phase 4 INHALE-3 study of its Afrezza DPI in type 1 diabetes patients. The trial is expected to enroll approximately 120 type 1 diabetes patients who currently use an insulin pump. Over the course of the 17-week study, one group will continue their usual insulin delivery method, and another group will use … [Read more...] about MannKind initiates Phase 4 INHALE-3 trial of Afrezza inhaled insulin
Phase 2a study of Pieris and AstraZeneca’s elarekibep DPI discontinued
According to Pieris Pharmaceuticals, AstraZeneca has stopped a Phase 2a trial of elarekibep (PRS-060/AZD1402), an inhaled IL-4 receptor alpha inhibitor that the companies were developing for the treatment of asthma. In the announcement, Pieris said that it has been informed by AstraZeneca that pathology results from a 13-week toxicology study of inhaled dry powder … [Read more...] about Phase 2a study of Pieris and AstraZeneca’s elarekibep DPI discontinued
Vistagen reports results of Phase 1 study of itruvone (PH10) nasal spray
Vistagen said that a Phase 1 study of itruvone (PH10) nasal spray, which the company is developing for the treatment of major depressive disorder, found that itruvone was well tolerated with no serious adverse events. The company had announced the initiation of the study to evaluate a new formulation of PH10 in January 2023. PH10 for the treatment of major … [Read more...] about Vistagen reports results of Phase 1 study of itruvone (PH10) nasal spray
FDA approves Lupin’s generic of Spiriva HandiHaler tiotropium bromide DPI
Lupin announced that the FDA has approved the company's ANDA for its generic of Boehringer Ingelheim's Spiriva HandiHaler tiotropium bromide inhalation powder. Health Canada approved the company's tiotropium DPI earlier this year. In the UK, the DPI was approved in August 2022. According to Lupin, the company manufactures the product at its site in Pithampur, … [Read more...] about FDA approves Lupin’s generic of Spiriva HandiHaler tiotropium bromide DPI
FDA extends the PDUFA target date for review of ARS’s NDA for Neffy intranasal epinephrine
According to ARS Pharmaceuticals, the FDA has extend the PDUFA target date for completion of its review of ARS's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions. The agency accepted the NDA for review in October 2022 and at that time, ARS said that the PDUFA date had been set for "mid-2023." The company says that the new PDUFA date … [Read more...] about FDA extends the PDUFA target date for review of ARS’s NDA for Neffy intranasal epinephrine