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european-pharmaceutical-review-issue-2-2024

european-pharmaceutical-review-issue-2-2024
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ISPE Announces Leaders from Health Canada, AltruBio, AstraZeneca, Gilead, Lonza, Lyndra, and More to Speak at the 2023 ISPE Annual Meeting & Expo

/PRNewswire-PRWeb/ The International Society for Pharmaceutical Engineering (ISPE) announced eight keynote speakers for the 2023 ISPE Annual Meeting & Expo,. ....

United States , North Bethesda , City Of Irvine , San Francisco , United Kingdom , Matthew Pearl , Celia Lourenco , Lonza Biologics , Flavius Martin , Judy Chou , Michael Lee Sherwood , Las Vegas , Kyle Haraldsen , Pam Cheng , Stevens Institute Of Technology , Research At Gilead Sciences Inc , Health Products , Akero Therapeutics Inc , Food Branch Of Health Canada , Rare Action Network , Altrubio Inc , Bayer Pharmaceuticals , Dana Farber Cancer Institute At Harvard , National Organization For Rare Disorders , Fanconi Anemia Research Fund Everylife Foundation , Fanconi Anemia Research Fund ,

Saniona AB: Saniona completes submission of manufacturing data for Tesomet capsules to U.S. FDA

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 ....

United States , Trista Morrison , Kyle Haraldsen , Drug Administration , Chief Technical Operations Officer , Chief Communications Officer , Nasdaq Stockholm Small ,

Investegate |Saniona AB Announcements | Saniona AB: Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA

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 facilitat ....

United States , Trista Morrison , Kyle Haraldsen , Drug Administration , Manufacturing Feedback , Chief Technical Operations Officer , Chief Communications Officer , Nasdaq Stockholm Small Cap , ஒன்றுபட்டது மாநிலங்களில் , ட்ரிஸ்டா மோரிசன் , தலைமை தொழில்நுட்ப செயல்பாடுகள் அதிகாரி , தலைமை தகவல்தொடர்புகள் அதிகாரி , நாஸ்டாக் ஸ்டாக்‌ஹோல்ம் சிறிய தொப்பி ,

Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA

Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA
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United States , Trista Morrison , Kyle Haraldsen , Drug Administration , Chief Technical Operations Officer , Chief Communications Officer , Abuse Regulation The , Nasdaq Stockholm Small Cap , ஒன்றுபட்டது மாநிலங்களில் , ட்ரிஸ்டா மோரிசன் , தலைமை தொழில்நுட்ப செயல்பாடுகள் அதிகாரி , தலைமை தகவல்தொடர்புகள் அதிகாரி , நாஸ்டாக் ஸ்டாக்‌ஹோல்ம் சிறிய தொப்பி ,