When a Sponsor Switches Technology Platforms, the Site Feels It First
A sponsor's mid-study clinical system migration lands on sites first: reconciliation work, documentation risk, and monitoring gaps nobody budgeted....
Psychiatry’s Stratification Crisis: How Biomarkers Are Finally Breaking the DSM’s Grip on Trial Design
Precision psychiatry biomarkers are reshaping CNS trial stratification — here's what the shift from symptom-based DSM criteria to biotype-driven...
Theravance files ampreloxitine investor presentation based on post hoc CYPRESS analysis
Theravance files ampreloxitine investor presentation based on post hoc analyses of its Phase 3 CYPRESS trial in multiple system...
Caliway’s CBL-514 Phase 2 Combination Trial Cleared; Phase 3 SUPREME-01 Enrolling
Caliway's Phase 3 SUPREME-01 trial for CBL-514 now enrolling patients. The pivotal study evaluates abdominal fat reduction using the...
The Oregon Dataset Is Larger Than the Entire History of Psychedelic Trials. So Why Are Regulators Still Looking the Other Way?
OHSU's 2,363-person Oregon psilocybin dataset dwarfs every RCT in the field's history. Here's what it tells us that clinical...
What a Coverage Analysis Actually Decides, And Where Auditors Actually Look
SOC vs RES is decided cell by cell in the visit grid, not procedure by procedure. Here is what...
Regenxbio’s Second Clinical Hold in Eight Months Exposes a Safety Monitoring System That Was Never Rebuilt After the First One
FDA hits RGX-121 with a second clinical hold in 2026 over spine MRI findings in 5 patients—revealing systemic monitoring...
Rapid Whole-Genome Sequencing Is Leaving the Research Ward and Entering the PICU Protocol — What Sponsors Need to Watch
Nature Medicine's citywide Dubai rWGS study and Seattle Children's 1,000-patient rollout signal a regulatory inflection point for genomic diagnostics...
BreakBio Enters Clinic for Personalized Cancer Vaccine
Personalized cancer vaccine enters clinical testing as BreakBio joins Moderna and BioNTech in the emerging field, targeting low-mutational tumors.
ATG-201 Clears Australian Approval for Phase I Trial in B-Cell Autoimmune Diseases
ATG-201 clears Australian approval for Phase I trial in B-cell autoimmune diseases, advancing dual-market enrollment with UCB partnership.