Abstract
Just like the Internet in 1990’s, Artificial intelligence is now changing all aspects of our life and work. It’s impact is beginning to show in the industry and it is changing the life-sciences practice by fundamentally altering the way how medicines are discovered, developed, manufactured, approved, supplied and brought to market.
In research and discovery, generative models and structure prediction systems shorten the path from target to lead and raise the ceiling…
Shots:
EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion
Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…

