FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases
Key Takeaway: The FDA is developing a “plausible mechanism framework” to facilitate approval of individualized therapies for the treatment of rare genetic diseases that currently face approval challenges. As discussed previously...
Is Your IP Ready? Navigating IP Challenges for Commercial-Stage Technologies in Due Diligence and M&A
Presenting as part of an LSI ’26 panel, Knobbe Martens partners Kregg Koch and Sabing Lee joined fellow panelists to explore the complexities of intellectual property management for commercial-stage technologies in the medtech industry, and the...
AI Is Going Nuclear: How Major Tech Companies Are Pursuing Nuclear Energy—And How Energy Startups Can Avoid Common Collaboration Pitfalls
Key Takeaways: As major technology companies turn to nuclear energy, early-stage nuclear companies may face heightened intellectual property (IP) risks due to asymmetric negotiations. Building and documenting strong background IP—and...