Featured Pharma Online Editorial

1. Gedatolisib Shatters Phase 3 Goals and Scales For Breast Cancer Breakthrough 8/11/2025

   After unprecedented phase 3 clinical trails of gedatolisib, Celcuity is working feverishly with its partners to get the drug ready to offer a new standard of care to those that suffer from advanced breast cancer.

2. The Rise Of NAMs 7/31/2025

   New Approach Methods (NAMs) are rapidly being accepted as replacements for preclinical animal tests long considered to be the gold standard. NAMs include systems of organoids, organs-on-chips, AI-based prediction models, and non-mammalian species.

3. The 3 Big Barriers To AMT Implementation 7/18/2025

   Advanced manufacturing technologies (AMTs) can not only lower costs but also improve the quality and consistency of both API and final dosage manufacturing in pharmaceuticals, so why are they not more widely implemented?

4. Can AMTs Make U.S. Pharmaceuticals Faster, Better, Stronger? 7/11/2025

   As the pharmaceutical industry prepares for impending tariffs and invests in domestic manufacturing, advanced manufacturing technologies present a viable opportunity to modernize systems for improved efficiency, consistent quality and potentially lower costs.

5. Scaling Up Manufacturing? Here's Why You Need A CMC Specialist 6/16/2025

   CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

6. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

7. 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.

8. 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).

9. Small Molecule Pharma Companies Are Employing These Advanced Technologies To Get Ahead 5/19/2025

   Small molecule drug companies are employing these concrete innovations, including several associated with Pharma 4.0, all boosting quality and efficiency.

10. A Road Map For PAT Monitoring And Control 5/8/2025

    Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.