Your DSCSA Responsibilities

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.

Bristol Myers Squibb discloses a patient death in its Phase I CAR-T multiple sclerosis trial, Pathos AI launches multi-year collaborations with Bristol Myers Squibb and Tempus AI to advance Alzheimer’s drug development, and health economist Dr. Nadine Zawadzki speaks with The Ron Lanton Report on how value is defined across healthcare.

Pfizer’s talazoparib-enzalutamide combination moves to earlier line in prostate cancer, with eligibility tied to genetic testing and immature survival data.

Bristol Myers Squibb discloses results from it's Phase I Breakfree-2 trial of CAR-T therapy zola-cel for multiple sclerosis.

Pathos AI launches multi-year collaborations to build an AI-driven dataset for Alzheimer’s and other neurological diseases.