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COTA Signs Agreement with FDA for Breast Cancer Research

In Clinical Trials by Barbara Jacoby

By: Drew Boxler From: drugtopics.com COTA Inc, a precision medicine technology company that uses real-world evidence (RWE) to bring clarity to cancer care, has signed an agreement with FDA’s science and technology incubator, Information Exchange and Data Transformation Program (INFORMED). The agreement will bring real-world evidence to the development of breast cancer treatments. Under the two-year research collaboration agreement, COTA …

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Leveraging Real World Evidence for drug approval

In Clinical Trials by Barbara Jacoby

By: Andrew Burrows From: knect365.com In 2016 the FDA introduced the 21st Century Cures Act, which allowed for the expansion of real world evidence in gaining approvals for new drugs. Following this Pfizer’s Ibrance, a CDK 4/6 inhibitor, was recently approved for the treatment of breast cancer in men by leveraging real world evidence. Whilst there are clearly exciting opportunities around the use …