Kexing Biopharm leans on IQVIA as biosimilar competition moves from China to global markets
Biosimilars need speed, but regulators still demand proof. IQVIA and Kexing test whether AI can cut friction without cutting evidence.
Why Bioxodes’ adaptive trial strategy could accelerate approval timelines in stroke therapeutics
Bioxodes advances BIOX-101 into pivotal trials for intracerebral hemorrhage. Find out how this strategy could reshape stroke treatment pathways.
Can early access programs reshape the approval arc for rare disease gene therapies?
GenSight Biologics S.A.’s early access rollout of GS010/LUMEVOQ in France and Israel has drawn new attention to how regulators are quietly repurposing compassionate use frameworks into strategic regulatory sandboxes for advanced therapies. As rare disease gene therapies edge closer to commercial viability, a patchwork of early access programs across key jurisdictions is beginning to influence […]
Vicarious Surgical bets on outsourced software execution to control costs and advance clinical timelines
Vicarious Surgical shifts software development to a global partner to cut costs and hit clinical trial milestones. Here’s what this means for its platform.