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.
On the same Monday, the FDA stopped one gene therapy over five asymptomatic MRIs from its own follow-up protocol — and reopened a review the advisory committee had voted dead. Plus the first oral drug for dermatomyositis, a tau tracer with a label, and US$380 million of cell-therapy automation gone.
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.
One email a week, the same content as this page. No sequence, no funnel, no sales follow-up — and an unsubscribe link in every issue.