Newsletter | April 17, 2025

04.17.25 -- AI Performance Management In Biologic And Drug Development

FEATURED EDITORIAL

How To Build Resilience Amid Dynamic Biopharma Vendor Relationships

The key to effective vendor management lies in understanding how relationships derail in the first place. Here are some common reasons and tips on how to avoid them.

AI Performance Management In Biologic And Drug Development

Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.

Trends In FDA FY 2024 Inspection-Based Warning Letters

Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

INDUSTRY INSIGHTS

A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

NEWS HEADLINES

Budget Impact Analysis Presented At IMKASID 2025 Shows Opportunity To Reduce Budgetary Pressures And Improve Treatment Accessibility With Ustekinumab Biosimilars In Europe

Biocon Biologics Announces U.S. FDA Approval For Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio

Teva And Samsung Bioepis Announce Biosimilar EPYSQLI® (eculizumab-aagh) Injection Now Available In The U.S.