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- Minghui Pharma sells Japanese rights to its Phase 3 thyroid eye disease drug for $110 million upfrontMinghui Pharmaceutical, a Shanghai‑based biotech, has agreed to transfer the Japanese commercial rights for its late‑stage thyroid eye disease candidate to a specialty pharmaceutical company. The…
- FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory workAI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that…