IP Considerations Following FDA Announcement on Flexibility for Cell and Gene Therapies
Key Takeaways: Manufacturing processes of cell and gene therapies (CGTs) may remain fluid well into development and even after FDA approval, and therefore sponsors of CGTs may benefit from patent...
New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.
Key Takeaway: New FDA guidance released on February 23, 2026, and March 9, 2026, signals a continued shift toward regulatory flexibility aimed at accelerating approval of biosimilar treatments for rare...
War in Iran Spotlights Innovation for Missile Interception Startups
Key Takeaways: The war in Iran is likely to accelerate innovation for defense technology companies. Innovation is particularly needed to develop low-cost missile interception technology. While established defense technology companies...