Weekly brief

What happened this week — and what it means for your programme.

Every week I read the clinical, regulatory and safety news so you do not have to — weighted towards neurology, neuroimmunology and the decisions coming out of the FDA and the EMA. One thing explained properly, five or six things summarised honestly, and a line under each one saying what it changes for a sponsor. No press-release voice, no hype, and every single item linked to the original source so you can check it yourself.

Published Thursdays. Written by a board-certified neurologist who spent twenty-two years inside clinical development, so the “what it means” line is a judgement, not a summary.

2026

1 issue
13 August 2026 · Issue 01

The week your contract manufacturer became the critical path

A court told the Pentagon to back off China's biggest CRO. Four days earlier, a clean clinical dossier was rejected because of somebody else's factory. Plus GDUFA IV, the first orexin agonist, and a surrogate endpoint that cost 92 % of a share price.

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