Regulatory

  1. Wall Street Is Wary Of NAMs — And For Good Reason: What Happens To Yesterday's Drugs? 9/15/2026

    Part 2 follows the consequences into Wall Street, asking what better evidence could mean for pharmaceutical valuations and, ultimately, drugs already in the portfolio.

  2. Pharmacovigilance Is Not A Checkbox: Rethinking Safety Monitoring From Day One 9/10/2026

    Cell and gene therapies demand a pharmacovigilance approach built from the ground up, not adapted from frameworks designed for conventional drug products.

  3. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

  4. Psychedelics EO May De-Risk Innovation, But Data Is Still King 7/15/2026

    A recent Executive Order (EO) de-risks psychedelic drug development by clarifying regulations, but scalable treatment models and rigorous data collection remain critical.

  5. Beyond The Fine Print: OPDP's 2026 DTC Letters Redefine Net Impression 6/29/2026

    FDA’s OPDP untitled letters show rising scrutiny of DTC ads’ overall impression on consumers and urge companies to balance benefit claims with clear product risks.

  6. Understanding FDA's Plausible Mechanism Framework For Genetic Medicines 6/19/2026

    FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.

  7. 5 Critical Risks With The FDA's Real-Time Trial Monitoring 5/8/2026

    Life science legal experts Kimberly Chew and Odette Hauke cover the FDA proof-of-concept real-time clinical trials (RTCTs) and expose five major issues that must be addressed before the pilot expands.

  8. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

  9. Understanding The EU Regulatory Landscape For Cell And Gene Therapies 4/9/2026

    EU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.

  10. Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease 2/19/2026

    The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.