PUBLICATIONS

Hatch-Waxman: The Underrated Power Tool in the Biotech Playbook Key Takeaways: Market exclusivity can be achieved without patents using new clinical data. Hatch-Waxman provisions provide 3-7 years of protection. Effective for drug repurposing, new formulations, and rare diseases. Align with 505(b)(2), Orphan Drug Designation, and Fast Track pathways to enhance value. Understanding and leveraging the Hatch-Waxman Act is crucial for biopharma success, particularly for Read more

Engaging Early with EMA Scientific Advice: A Strategic Advantage for Sponsors For companies planning clinical trials or pursuing marketing authorization in the European Union (EU), early engagement with the European Medicines Agency (EMA) through its Scientific Advice procedure can be a game-changing strategy. This is especially true for small to mid-sized developers and non-EU sponsors who may be less familiar with the European regulatory environment. Understanding Read more

FDA vs. EMA: Navigating Divergent Regulatory Expectations for Cell and Gene Therapies. What Biopharma Companies Need to Know Key Takeaways for cell and gene therapies (CGTs)  Stakeholders Regulatory divergence increases complexity – US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have different trial design expectations, approval pathways, and post-market requirements, making a single regulatory approach ineffective. FDA offers faster approval but with uncertainty – Expedited pathways (RMAT, Fast Track, Read more

Clinical Research Focus. 39th Edition Gepotidacin Receives FDA Approval for UTI Treatment The FDA has approved GSK’s gepotidacin (Blujepa) for treating uncomplicated urinary tract infections (uUTIs) in females aged 12 and up. Backed by strong results from the EAGLE-2 and EAGLE-3 Phase 3 trials, this is the first new oral antibiotic for uUTIs in over two decades—a significant milestone in Read more