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

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

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 ...

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

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 ...

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 ...

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

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 ...

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

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 ...

Neuland's Saharsh Davuluri checks in on Chinese out-licensing, peptide capacity, and CDMO agility six months after his December 2025 predictions. Access Part 1 of this interview, in which Davuluri ...