The acquisition brings two commercialized, differentiated medicines—EMPAVELI and SYFOVRE —to Biogen’s growth portfolio
Enthral.ai’s platform integrates AI-driven capabilities with compliance-first architecture, enabling automated training workflows
A key milestone in this journey has been the introduction of TREAT Program, a first-of-its-kind clinical initiative introduced in India
The new regimen, delivering 50 mg/5 mL and 28 mg/5 mL doses, offers a higher concentration of the drug for both loading and maintenance phases
Lonza will take on technology transfer, process optimization, and cGMP manufacturing, leveraging its global network and expertise in highly potent compounds
The investigational new drug application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate aimed at solid tumors
The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN
The decision is based on the phase 3 DESTINY-Breast11 trial
The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework
The approval covers pediatric patients without a matched sibling donor for stem cell transplant
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