Featured Pharma Online Editorial

  1. From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna 3/17/2026

    BioNTech’s new lawsuit against Moderna highlights the intensifying post-COVID mRNA patent wars, as companies clash over vaccine design, delivery technologies, and the future of RNA therapeutics.

  2. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

  3. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

  4. Trends In FDA FY 2025 Warning Letters 3/13/2026

    The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

  5. Raising The Bar In Radiopharmaceutical Manufacturing 3/12/2026

    Ratio Therapeutics chief commercial and manufacturing officer, Scott Holbrook, joined me to discuss how his team at Ratio Therapeutics is tackling the challenges of radiopharmaceutical manufacturing.

  6. What To Know About — And How To Apply For — FDA's PreCheck Pilot 2/23/2026

    FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.

  7. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

    Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

  8. At Base Camp: Lilly's Manufacturing Capacity Journey 2/13/2026

    In 2025 alone, Lilly announced plans to build new facilities in Texas, Alabama, Virginia and Pennsylvania in addition to facility expansions in Indiana, Wisconsin and Puerto Rico.

  9. The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality 2/13/2026

    The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."

  10. Solving The Top 3 Pharma Packaging/Manufacturing Issues 2/5/2026

    Regulatory changes, space/footprint constraints and expanding automation garnered more votes than the other challenges. Let’s explore these challenges, and see how the industry is tackling them as we move into 2026.