Featured Articles

  1. Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals 1/14/2025

    Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.

  2. Unlocking The Potential Of AI In Pharma: The Power Of Data Systems 1/10/2025

    Clean, humanized data and data systems are the crucial fuel for engines driving new AI capabilities and uses across the biopharmaceutical industry. Data integrity, accessibility, and ethical use of data are prerequisites for turning data systems and AI into trusted allies.

  3. Growing Your Life Science Business? Consider The Location 1/8/2025

    When looking for a place to grow a life sciences business over the long term, sometimes the biggest location isn't necessarily the best.

  4. Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ 1/6/2025

    The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

  5. Trends In Proposed Laws Aimed At Drug Patents 12/23/2024

    Where are legislative trends pointing on biopharmaceutical patents? Sona De, a partner at Sidley, reviews existing proposals and offers thoughts on what's to come in 2025.

  6. Tackling The Pharmacovigilance Crunch At The Local Level 12/19/2024

    Local market pharmacovigilance (PV) requirements can be daunting to manage successfully. Experts at PharmaLex provide best practices for managing PV across local affiliates.

  7. Antibodies 2025: Venerable & Naked Or Complex & Multi-Specific? 12/19/2024

    Antibodies are the biotherapeutic bulwark, the steadfast stalwart in not just oncology, but infectious and chronic inflammatory diseases as well. We consulted with a variety of antibody developers for insight into the challenges and opportunities antibody modalities face in the coming year and beyond.

  8. A Father's Perspective On The Rare Pediatric Disease PRV Program 12/17/2024

    The FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program is set to expire on December 20, 2024, if the U.S. Senate doesn't act. Stuart Siedman explains why the program is so important.

  9. A Realistic Look At What RFK Jr. Could Mean For FDA 12/17/2024

    “Make America Healthy Again” is coming to Washington. Jennifer D. Newberger and Jeffrey N. Gibbs at Hyman, Phelps, & McNamara, discuss the implications of RFK Jr.’s nomination to lead HHS. 

  10. Inside Interius' Global Regulatory Strategy 12/13/2024

    Interius BioTherapeutics' lentiviral gene therapy INT2104, which creates CAR T and CAR NK cells in vivo, headed to clinical trials in Australia where the company dosed a first patient with a B-cell malignancy. CEO Phil Johnson, M.D. gave us a look inside the company's global regulatory strategy.