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- Sionna’s cystic fibrosis candidate misses primary endpoint in Phase 2 trial, shares plungeSionna Therapeutics announced that its experimental cystic fibrosis drug SION-719 failed to meet the primary endpoint in a Phase 2 trial that added the drug to Vertex Pharmaceuticals' Trikafta. Th…
- Early regulatory operations planning key to submission-ready dossiersRegulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…