FDA Floats Oncology Authorization Shake-Up, Pitching ‘One-Trial’ Model for Accelerated and Full Approval
In draft guidance, the FDA outlined plans to move away from single-arm studies and instead favor randomized controlled trials that can potentially serve as the basis for both accelerated and full approval.
[EMBO Journal] Using a variety of in vitro and in vivo techniques, researchers showed that metastatic prostate cancer cells acquire a specific Na+/Ca2+ signature required for persistent invasion.
[Molecular Cell] Investigators explored the role of minor intron-containing genes and minor spliceosome in cancer, taking prostate cancer as an exemplar.
[Nature Communications] The authors uncovered dual-phosphorylated form of sterol regulatory element-binding protein 1 (SREBF1), pY673/951-SREBF1 that acts as an androgen sensor, and dissociates from androgen receptor in androgen deficient environment, followed by nuclear translocation.