Newsletter | January 9, 2026

01.09.26 -- Høeg In, Pazdur Out At The FDA

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INDUSTRY INSIGHTS

Introducing Laminar Airflow Technology In Aseptic Processing

The global market for injectable drugs will reach $69.13 billion by 2028. Examine the vital role of laminar airflow technology in meeting sterile integrity standards and minimizing contamination risks.

Work With An In-Country Depot For Efficiency And Compliance

If you’re launching an international clinical trial, consider the noteworthy benefits of partnering with an in-country depot, including increased efficiency, reduced costs, and reliable access to raw materials.

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

FEATURED EDITORIAL

Høeg In, Pazdur Out At The FDA

What an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.

INDUSTRY INSIGHTS CONTINUED

Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems

In the event of an IV bag leak, contaminants can adversely affect the solutions within. Learn how the reference standard for CCIT, USP 1207, applies to the CCIT inspection method of IV bags.

Expanding The Viscosity Limits Of Peristaltic Dosing

Discover how innovations in closed-loop control and mechanical design extend peristaltic dosing limits to 2000 cP, maintaining accuracy while preserving the advantages of sterile, disposable paths.

Spray-Dried Bevacizumab: Treating Non-Small Cell Lung Cancer

The development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

Continuous Manufacturing For API Breakthroughs

Observe how a compound library, designed for chemical diversity and lead-like properties, uses advanced filtering to improve hit discovery and early-stage small molecule drug discovery.

Integrated Annex 1 Compliance

Read about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.

Enabling The Future Of Intensified Biomanufacturing

Process intensification demands smarter orchestration, real-time analytics, and scalable automation. Discover how digital infrastructure enables synchronized, compliant, and predictive biomanufacturing.

Exploring The Challenges Of Cell Dissociation In Vaccine Manufacturing

Vaccine manufacturing relies on efficient cell dissociation methods. Explore the challenges of traditional approaches like trypsin and the benefits of animal origin-free alternatives for improved workflows.

Ringing The Alarm: Unified Data For GMP Annex 1 Compliance

Alarm monitoring can be more than compliance. Explore how unified data and real-time insights helped one pharma company unlock efficiency, predictive analytics, and a path to digital transformation.

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SOLUTIONS

Two Decades, One Focus: Sterile Manufacturing Excellence

Our Biotech Success — Surrozen

Containment Equipment For CDMOs

The Future Of Glass Packaging Is Here

Advancing Precision And Automation In Injectable Drug Delivery

Multi Shaft Mixers For Complex Formulations

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