Lily’s Legal Woes Due to Compounded Copies of Its Blockbuster Drug

Eli Lily has been trying to rein in compounding pharmacies from selling compounded versions of its super blockbuster anti-obesity drugs for more than a year now, unsuccessfully, and in the process establishing precedence for the rights of such unauthorized legal versions of approved drugs that would have an impact on other similar scenarios. Compounding pharmacies … Read more

FDA’s New Center for Clinical Trial Innovation: Would it Help the Sponsors?

Since the publication of the Critical Path Initiative over two decades ago which included smart trial designs, the FDA has introduced several innovative clinical trial designs to improve clinical trial conduct and expedite new drug developments. However, the adoption of those non-conventional designs has not yet become mainstream. Most clinical trials still follow traditional designs … Read more