Liquid biopsy represents potential advantages over traditional approaches to cancer surveillance, treatment selection and recurrence monitoring. But one size does not fit all, requiring tailored solutions for less developed markets.

ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.

Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.

The US- and China-based biotech is expanding three oncology-centered clinical studies of two TGF-1/COX-2-targeted siRNA drug candidates from the US into China.