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- Amid bepirovirsen triumph, GSK quietly scraps trial of next-gen hep B therapyGSK may have cemented its hepatitis B credentials with Tuesday’s landmark FDA nod for its “functional cure” bepirovirsen, but the pharma continues to rethink its strategy for next-gen candidates.
- Pharma companies push FDA for risk-based flexibility in container-closure testing guidanceMajor pharma firms have written to the FDA urging a shift in its current guidance on testing container-closure systems for drug and biologic products. They argue that a risk-based, flexible approa…