PUBLICATIONS

Clinical Research Focus. 40th Edition FDA to Phase Out Animal Testing for Monoclonal Antibody Drugs The FDA announced plans to phase out animal testing requirements for monoclonal antibody therapies, encouraging the use of New Approach Methodologies (NAMs) like AI models and human cell lines. A pilot program will test these alternatives, aiming to improve drug safety, cut costs, and speed Read more

World Asthma Day 2025: A New Era in Respiratory Care Today marks World Asthma Day — a global moment to reflect on the progress made in respiratory health, and to recommit to solving the challenges that remain. Asthma affects over 262 million people worldwide, claiming hundreds of thousands of lives every year. And yet, the way we respond to severe asthma flare-ups has barely evolved Read more

CT Scans and Future Cancer Risk: Time to Recalibrate How We Use Imaging A major new study published in JAMA Internal Medicine estimates that computed tomography (CT) scans performed in 2023 could lead to over 100,000 future cancer cases in the US—an alarming projection that may place CT as the source of up to 5% of all new cancer diagnoses annually, if current practices continue. This updated risk Read more

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