
News|Videos|September 25, 2026
PharmTech’s Weekly Roundup—September 25, 2026
Author(s)Susan Haigney
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
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This week, new modalities keep raising the manufacturing bar even as regulators race to modernize the rules around them, and artificial intelligence (AI) is showing up in validated environments as both a promised efficiency and a complication for quality teams. From weekly insulin to oral oncology combos to a new EU-cleared triple-therapy inhaler, the chemistry, manufacturing, and controls (CMC) complexity keeps climbing, right alongside the debate over how much oversight AI-assisted work needs.
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On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.

Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.

The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.

In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.

The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.

The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.

This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
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