Regulatory Articles

  1. Charting The Future Of Antimicrobial Resistance 1/21/2026

    We caught up with Ajit Parhi, Ph.D., CSO of TAXIS Pharmaceuticals, to discuss policy, precision science, and AI in battling antimicrobial resistance.

  2. Room For Improvement: Reformulating Existing Therapeutics 12/30/2025

    We caught up with Jed Litwiniuk, CEO, and Uwe Tigör, CMO, to talk about Auxilius Pharma’s work to improve and reformulate a treatment for chronic stable angina pectoris.

  3. Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up 12/5/2025

    Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.

  4. How The U.S. Can Beat China In Biotech 11/3/2025

    Lumen Bioscience's Brian Finrow breaks down China's biotech playbook and explores ways the U.S. can adapt it for its own continued success.

  5. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

    Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

  6. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

  7. Can America's Retreat On mRNA Be Europe's Opportunity? 8/28/2025

    With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.

  8. The OBBBA: Biopharmas Unlock R&D Expensing, Global Tax Efficiencies 8/28/2025

    Biopharma innovators may soon see major tax breaks thanks to the One Big Beautiful Bill Act (OBBBA). The new legislation introduces targeted tax incentives designed to strengthen domestic R&D and capital investment.

  9. How CZ Biohub's AI Agents Might Assist Drug Developers Beyond R&D 8/15/2025

    Researchers at Stanford and the Chan Zuckerberg Biohub San Francisco developed an open-source platform of virtual researchers who talk to each other.

  10. Heart-In-A-Jar Organ Model Earns Regulatory Respect After 25 Years In The Making 8/7/2025

    Aligned with new FDA support for new approach methodologies (NAMs), Ronald Li, Ph.D, and Kevin Costa, Ph.D., share their story of creating Novoheart's mini heart organ model and discuss its current use in clinical trials.