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FDA Expanded AI; Leadership Turnover Leaves Pharma With New AI Questions

The FDA has expanded artificial intelligence across regulatory reviews, inspections, and administrative work. However, the departure of former commissioner Dr. Marty Makary and other senior technology leaders has created uncertainty around the agency’s AI strategy. Although the FDA continues to
  • News
FDA Expanded AI; Leadership Turnover Leaves Pharma With New AI Questions

Ashlins Calls Interferon Alpha-2b De-Risked; FDA Evidence Gap Remains

Ashlins Pharmaceuticals has licensed ex-China rights to develop products using Lee’s Pharm’s interferon alpha-2b API in a deal worth up to $31 million. The rare disease startup now plans to raise about $50 million and believes the funding could take
  • News
Ashlins Calls Interferon Alpha-2b De-Risked; FDA Evidence Gap Remains

History of Pharma Digitalization in 2026: Digital Transformation to Pharma 4.0

This article traces the evolution of pharmaceutical technology from controlled electronic records and process analytical technology to connected manufacturing, AI oversight, and Pharma 4.0, showing how digital systems reshaped GMP evidence, data integrity, and inspection readiness.
  • Blog, Computerized System Validation
Pharmaceutical manufacturing line showing process analytical technology, connected digital systems, real-time quality data, and Pharma 4.0 operations.

FDA Leadership Shake-Up; Permanent CDER and CBER Chiefs Could Shift Review Priorities

The FDA reportedly plans to appoint permanent leaders for CDER and CBER when the White House names its next commissioner nominee. This FDA leadership reset aims to stabilize two centers that shape major drug and biologics decisions. However, pharmaceutical companies
  • News
FDA Leadership Shake-Up; Permanent CDER and CBER Chiefs Could Shift Review Priorities

Verseon Challenges AI Drug Discovery; Can Novel Molecules Pass Validation?

Verseon has challenged one of pharma’s strongest AI drug discovery promises: that data-driven models can consistently create truly novel medicines. In a July 22, 2026 report, the Bay Area drug developer argued that most AI platforms remain tied to known
  • News
Verseon Challenges AI Drug Discovery; Can Novel Molecules Pass Validation?

Digitalization in Pharma Industry in 2026: The Complete Guide to Digital Quality and Pharma 4.0

Explore how Pharma 4.0, smart manufacturing, IoT, artificial intelligence, and digital quality management reshape pharmaceutical operations. This guide explains the GMP controls, data integrity safeguards, validation evidence, and inspection-ready practices companies need for secure digital transformation.
  • Blog, Computerized System Validation
Pharma 4.0 manufacturing facility using IoT, digital quality management, advanced analytics, and artificial intelligence in pharmaceutical manufacturing.

Novo Sues Lilly; Missing Wegovy Dose Sparks GLP-1 Compliance Battle

Novo Nordisk filed a federal lawsuit against Eli Lilly in New Jersey on July 21, 2026, accusing the company of misleading consumers through national advertising for Zepbound and Mounjaro. Novo claims Lilly compared its highest drug doses with lower doses
  • News
Novo Sues Lilly; Missing Wegovy Dose Sparks GLP-1 Compliance Battle

Hospital AI Warning; The Same Tools Could Threaten Pharma’s GxP Systems

Karen Habercoss, chief information security and privacy officer at the University of Chicago Medicine, warned that hackers and nation-states now use AI to automate and scale cyberattacks. Her warning extends beyond hospitals. In pharma operations, the same technology supporting QA
  • News
Hospital AI Warning; The Same Tools Could Threaten Pharma’s GxP Systems

CSV in 2026: Computer System Validation for GMP Compliance

Computer system validation in pharma helps companies protect electronic records, control GxP risks, and maintain compliance throughout the validation lifecycle. This guide explains risk-based testing, audit trail review, access control, change control, and inspection-ready evidence.
  • Blog, Validation and Qualification
Pharmaceutical quality specialist reviewing a GxP dashboard for computer system validation in pharma, including audit trail review, access control, testing, and change control.

BMS Builds a Pharma AI Supercomputer: Why Validation Just Got Harder

Bristol Myers Squibb announced on July 20, 2026, that it will expand its artificial intelligence infrastructure through a new NVIDIA DGX SuperPOD equipped with Vera Rubin NVL72 systems. BMS plans to use the infrastructure across several research areas, including oncology,
  • News
BMS Builds a Pharma AI Supercomputer: Why Validation Just Got Harder