SPOTLIGHT: FDA questions satraplatin


Shares of GPC Biotech and Spectrum Pharmaceuticals took a big hit on Friday after the FDA raised questions regarding their cancer drug satraplatin. Analysts were alarmed that the agency was highlighting a disagreement between two radiologists over the progression of prostate cancer in patients who have failed to respond to chemotherapy. Reviewers may ask for a delay on any decision until final survival data is in. An expert FDA panel is scheduled to review the drug this week. Report

Suggested Articles

Chi-Med has detailed plans to seek approval from the FDA later this year in part on the strength of data from Chinese phase 3 trial.

The clamor for more transparency from the leading pandemic vaccine contenders has been getting louder.

The role gives one of the driving forces behind Bristol Myers Squibb’s $74 billion takeover of Celgene the chance to help build biotechs.