FDA has approved the first liquid biopsy test to detect genetic mutations linked to drug response in patients with non-small cell lung cancer. Roche's cobas EGFR Mutation Test v2 could be a game-changer in helping to diagnose certain NSCLC patients without requiring a tumor biopsy, the agency suggests.

In overwhelmingly concluding that efficacy has not been demonstrated for the mesenchymal stromal cell therapy, panelists went beyond just the failed Phase III trial and cited BrainStorm’s ‘statistical magic’ and failure to adequately describe the mechanism of action, as well as safety and product quality concerns.

The other seven drugs on the initial list for negotiation are already heavily rebated and CMS could choose not to go much lower than current net prices, SSR Health report points out.