EMA starts drawing lines around external control arms
Amsterdam is finally writing down what counts as a credible non-randomised comparator, just as a year of methods papers shows how often submissions still skip the basics.
Biostatistics
Pfizer's $10B Innovent bet meets the China-data reckoning
A $10B Pfizer-Innovent pact, a House bill to sweep biotech into COINS, and two China-only ASCO plenaries land in one week — and the bridging-study question is suddenly on the critical path.
FDA opens the door to platform borrowing in genome editing
CBER's draft guidance on "prior knowledge" lands the same week three in vivo cell and gene readouts make the question of borrowing unavoidable. Comments close September 1.
The evidence-synthesis stack is being rebuilt, all at once
An arXiv preprint hands clustering decisions to an LLM while a cluster of new JCE papers concedes that GRADE, PRISMA-P, and guideline appraisal each need patching. The substrate under every HTA dossier is moving.
TEMPO lands while wearable endpoints still wobble
FDA wants real-world performance data on digital health devices via a CMS-linked pilot — at the same moment its own wellness exemption let unvetted blood-pressure and glucose features ship to consumers.
CRT inference: three papers, one estimand problem
The cluster-randomized headline number is doing less work than it looks. May–July 2026 brought a closed-form bias proof, a reporting indictment, and a workaround that sidesteps the ICC entirely.
Who Designs the Trial Is Now a Regulatory Variable
Two new audits — 15 years of LMIC authorship, and SARS-CoV-2 vaccine eligibility criteria — turn diversity rhetoric into an estimand problem sponsors will be asked about.