Guidance for Industry - Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers

Astellas and Seattle Genetics impressed Wall Street last fall when their combination of Padcev and Merck’s Keytruda fought off advanced bladder cancer in previously untreated patients. Friday, the partners presented updated results that look even better—perhaps good enough to help drive the med to $5.8 billion in peak sales.