Leading manufacturers now deploy validated agentic AI that detects OOS events, retrieves batch records, correlates prior deviations, and drafts RCA packages, yielding ≥50% faster investigations.

According to Schniepp, inspectors are not auditing the electronic submission mechanism itself because the eCTD system is ...

AI is reshaping discovery, manufacturing, and supply chain routing. Manufacturers are investing in capacity and resilience. In news this week, Novo Nordisk has sued Eli Lilly, alleging its Zepbound ...

Campbell Bunce, chief scientific officer at Abzena, provides an update on the momentum in antibody-oligonucleotide conjugates development and the operational pressures shaping CDMO/CRO strategy for ...

A 2026–2027 joint work program operationalizes EMA–EISMEA cooperation to move European Innovation Council-funded projects ...

Megha Sinha, founder and CEO of Kolter AI and Kamet Consulting Group, spoke with PharmTech at the beginning of 2026 about her ...

A distributed “hub-and-spoke” operation could register as one establishment, reducing administrative friction while improving ...

Campbell Bunce, chief scientific officer at Abzena, revisited his 2026 industry predictions on the direction of the biologics and bioconjugate market and gives an update on ADCs. Campbell Bunce, chief ...

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at ...

Novo Nordisk challenges nationwide Zepbound/Mounjaro advertising as misleading comparative promotion, citing omitted disclosure of the most effective FDA-approved semaglutide injectable doses. One ...

Megha Sinha, Kolter AI, discusses how pharma's AI bottleneck shifted from technology to readiness as execution across 60 ...

BMS will deploy NVIDIA DGX Vera Rubin NVL72, citing up to 10× performance per megawatt versus prior architecture, enabling larger models without proportional energy growth. Expanded compute is ...