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

Regulatory Optimisation Group efforts are converging on a future-state lifecycle change process, shifting from document-based ...

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

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

This week, the industrialization of advanced biologics, sustained regulatory and investment momentum behind next-generation therapeutics, and an ongoing push across the supply chain to improve ...

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

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

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

Megha Sinha, Kolter AI, talks on how orchestrator roles surged in pharma AI, but teams need computed plans, not titles, to close the skills gap. Megha Sinha, Kolter AI, discusses how digital twins run ...

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

Economic asymmetry after cartridge introduction drives a design philosophy centered on minimizing false acceptances and protecting API, with >99.5% first-pass yield as the principal success criterion.

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 ...