Featured Pharma Online Editorial

1. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

   A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

2. What Did ICH Q14 Miss On Analytical Method Validation? 7/7/2025

   Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.

3. Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet 6/19/2025

   This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.

4. Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms 6/5/2025

   Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

5. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

   The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

6. Lilly's Calculated Approach To Upgrade Trade-Offs 5/22/2025

   If the disruption of implementing and adapting to new technology costs more than its benefits, teams should proceed cautiously.

7. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

   The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

8. ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy 5/12/2025

   Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.

9. Why Pharma Risk Assessments Should Include 'Working Together Alone' 4/16/2025

   When understood and managed properly, subjectivity becomes a source of creativity. It reveals hidden hazards and unlocks more effective risk controls.

10. Oral Therapies Take Center Stage For PsO And PsA Treatment 4/1/2025

    The recent American Academy of Dermatology 2025 Annual Meeting in early March saw major updates for two key oral therapies in autoimmune diseases.