Featured Pharma Online Editorial

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. AI Model Cards Make Function And Risk Easier To Understand 3/31/2025

   AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.

7. The Technologies Propelling GLP-1 Analogues 3/18/2025

   This article delves into the manufacturing and synthesizing technologies used to manufacture GLP-1 drugs as well as the novel drug delivery technologies being used.

8. Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product 3/10/2025

   Brush up on guidance on how to demonstrate that a foreign-sourced reference drug is acceptable to the Minister of Health as a Canadian reference product for an Abbreviated New Drug Submission and Abbreviated Extraordinary Use New Drug Submission.

9. EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety 2/28/2025

   There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation and how to make assessments. The public comment period ends April 30.

10. Areas For Advancement In Peptide Manufacturing 2/27/2025

    Experts from Eli Lilly, NervGen, and Piramal Pharma Solutions discuss the myriad of ways peptide manufacturing can be improved, drawing on years of industry experience and insight.