BIOTECHNOLOGY

Andrew Barnell, CEO and co-founder of Geneoscopy. “With the goal of expanding cancer screening options and improving outcomes for millions of patients, Geneoscopy seeks to ensure that Exact Sciences does not foreclose innovation and advancement in the field of cancer detection by claiming exclusive rights to diagnostic methods it did not invent. We strongly deny Exact Sciences’ allegations and will vigorously defend our ability to fulfill our mission to empower patients and providers to transform gastrointestinal health.”

SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co. Ltd., a global biotech company, is using Veeva Vault Validation Management to streamline and accelerate their validation process. By adopting a validation solution with built-in best practices, the company can execute digital validation while centralizing data and improving visibility.

This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer. The FDA also issued a new postmarketing requirement for an additional confirmatory study to support full approval that will be completed no later than February 2028.