european-pharmaceutical-review-issue-2-2024 europeanpharmaceuticalreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from europeanpharmaceuticalreview.com Daily Mail and Mail on Sunday newspapers.
/PRNewswire-PRWeb/ The International Society for Pharmaceutical Engineering (ISPE) announced eight keynote speakers for the 2023 ISPE Annual Meeting & Expo,.
PRESS RELEASE 18 October 2021 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that it has completed the submission of all information
manufacturing
. Saniona anticipates that addressing these requests will delay the start of the Phase 2b trials of Tesomet for Prader-Willi syndrome (PWS) and hypothalamic obesity (HO) into the second half of 2021.
Tesomet is an investigational fixed-dose combination of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). In preparation for Phase 2b through Phase 3 clinical trials and eventual commercialization, Saniona has taken multiple steps to optimize the manufacturing of Tesomet, including transitioning from tablets to capsules. The company chose to utilize a capsule form because some individuals with PWS and HO have a tendency to chew tablets, which would disrupt the performance of the fixed-dose combination. The Tesomet capsules contain the two active ingredients as microspheres, which are expected to minimize the impact of chewing or biting. Additionally, capsules are generally easier to swallow than tablets and facilitate the dev
Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U S FDA apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.