Moving Towards A Total Lifecycle Regulatory Approach For AI Devices

Regenxbio is riding a wave these days, with all three of its clinical-stage programs set to reach critical milestones this year and recent positive news on its DMD gene therapy, just as Sarepta suffered a setback with a death related to its DMD treatment. In Vivo spoke with CEO Curran Simpson about the company’s plans and strategic decisions.

In the pharma and cosmetic sectors, innovation often arises from new uses for known compounds. While the compounds may not be patentable, their new applications can be. European law allows patents on substances used in medical methods, but not on the methods themselves.

In the wake of a series of unprecedented executive orders from US President Trump, the EU medtech industry faces significant political, regulatory and business challenges. Swift and strategic action is essential to ensure stability and safeguard patient safety.

Germany’s Union parties may have little alternative than to bring the SPD into a new four-year coalition, says Clifford Chance partner and life sciences legal expert Gunnar Sachs. Health policy will likely see both textural and structural changes.