Thursday mornings, before nine Central. Five or six items from the week's peptide science and regulatory record, each with a sentence or two on what it establishes — and, often, on why it is less interesting than the headline made it sound.
Subscribers receive the full text. Summaries below.
A cardiovascular outcomes paper published this week reported a composite primary endpoint driven largely by one of its three components — a pattern worth recognising, since the headline figure looks identical either way. Also: an updated pharmacopeial chapter on chromatographic system suitability, and a correction to our 9 July description of a 2023 guidance document's scope.
The sponsor briefing document and the agency review memorandum for a recent advisory committee disagreed on how to characterise a subgroup finding, and both are public. We walked through where the disagreement actually sits. Term of the week: prespecified, and why it is doing more work than most readers realise.
A preprint circulating widely on social media had been revised twice since the version being screenshotted, with a materially different results table in the current draft. How to check which version you are reading, and why the posting date on a share is not the date of the science. Plus a new international standard on laboratory accreditation scope statements.
A public comment period closed this week with a handful of submissions, most from trade bodies. We summarised what was filed, by whom, and what the nomination process does and does not determine. Also: a methods paper on peptide impurity profiling that is better than its abstract suggests.
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