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Earlier pediatric planning, innovative trial design, and closer collaboration among regulators, industry, and families are needed to close the persistent gap between the evidence available for adult and pediatric treatments.

BioMarin licenses long-acting Fabry enzyme replacement therapy HM15421/GC1134A, while Ferring agrees to acquire fertility biotech Gameto.

As AI accelerates drug discovery, the industry’s next challenge is building a connected, standards-based data infrastructure capable of supporting it through clinical development.

Shionogi’s Dr. Draica on why mild COVID-19 can worsen chronic conditions for up to a year — and why prevention matters more than hospitalization data suggests.

Brock.AI’s Hamish Brocklebank on recruiting 8% of all US pancreatic cancer prescribers — paying $2,000 an hour, offering equity, and triple opt-in consent.

Astellas gains an option on Audax’s IL-12 antibody-cytokine fusion DAX-044, while EVERSANA acquires London-based health economics firm Estima Scientific.

Shionogi’s Dr. Draica on why preventative antivirals matter — and how its HIV and flu prevention heritage shaped XOCOVA’s post-exposure focus.

The infrastructure decisions companies make today could determine how quickly they capitalize on new computational capabilities

Brox.AI’s Hamish Brocklebank on three levels of digital clone use cases — from HCP content testing and GLP-1 price sensitivity modeling to simulating physician adoption after FDA approval.

Teva acquires BioXcel’s BXCL501, under FDA review for at-home agitation use; Rumi Therapeutics gains an option on Enthorin’s Fragile X PDE2 inhibitor.

Brox.AI’s Hamish Brocklebank on the three approaches to digital twins in pharma — and why only one-to-one clones of real individuals deliver true accuracy.

Shionogi’s Dr. Draica on how XOCOVA blocks viral replication between exposure and symptoms — and why it works even with prior immunity.

Phagenyx’s Chad Hoskins on why AHA/ASA guideline inclusion gives stroke teams a basis to use PES earlier — and what the evidence shows.