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Report: FDA reviewers' findings complicate interim peptide compounding plan

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Photo: The Building Envelope / StockSnap (CC0) / own upload

FDA Webview reported on 9 October that a temporary enforcement-discretion policy under consideration, which would let compounding pharmacies dispense certain unapproved peptides while permanent rules are written, could put the administration at odds with the agency's scientific reviewers. According to the report, FDA reviewers had found limited evidence of safety and effectiveness for the seven peptide substances the Pharmacy Compounding Advisory Committee considered in July, and the committee's recommendations were nonbinding. The report notes that such a policy would not amount to FDA approval and that no final decision or timetable has been disclosed.

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For research-community awareness only. Not legal advice.

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Hidden peptide tells a plant-infecting fungus it has entered its host

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Photo: Matt Bango / StockSnap (CC0) / own upload

Researchers led from Heinrich Heine University DΓΌsseldorf reported in Nature Communications on 9 October that the corn smut fungus secretes a protein, Pit2, which plant proteases cut to release a hidden peptide. The peptide activates a fungal G-protein coupled receptor, Gpe1, which promotes fungal proliferation after host entry; mutations that disrupt the pair lowered virulence. The work concerns a plant pathogen and involves no animal or human data.

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Unexpected hydantoin impurity found in routine peptide N-terminal acetylation

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Photo: HD Wallpapers / StockSnap (CC0) / own upload

Process chemists at Ferring Pharmaceuticals reported in Organic Process Research & Development on 8 October previously unreported hydantoin impurities that formed when peptide N-termini were capped with acetic anhydride under common conditions. Formation depended strongly on solvent and sequence, isotope labelling pointed to the solvent taking part in the side reaction, and the authors identified conditions that suppressed it.

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Expert panel sets 26 standards for benchmarking peptide-target prediction

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Photo: HD Wallpapers / StockSnap (CC0) / own upload

An international panel coordinated from Imperial College London reported in Frontiers in Bioinformatics on 9 October PTI-TAPE, a framework for evaluating computational predictions of peptide-target interactions, agreed through a three-round eDelphi study with 15 experts. It sets 26 standards across eight domains, including primary metrics, a hierarchy for negative examples that favours experimentally confirmed non-binders, and mandatory time-based data splits.

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AI-designed peptide probe images TROP-2 in mouse tumour models

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Photo: Vidsplay / StockSnap (CC0) / own upload

Researchers at Fujian Medical University and collaborators reported in Bioconjugate Chemistry on 8 October TR23, a TROP-2-binding peptide designed de novo with an AI platform that mimics a protein binding interface. Labelled with gallium-68 for PET imaging, the probe bound TROP-2 with nanomolar affinity, was taken up selectively by TROP-2-positive cells and gave specific, high-contrast signals in three mouse xenograft models. The work is preclinical.

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New algorithm identifies peptides in quadrupole-free ion mobility data

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Photo: Vidsplay / StockSnap (CC0) / own upload

Researchers at Cedars-Sinai Medical Center and MOBILion Systems reported in Analytical Chemistry on 9 October xTracer, an algorithm for identifying peptides in mass spectrometry data from mobility-aligned fragmentation without quadrupole isolation. By correlating chromatographic and mobility dimensions to link precursor and fragment ions, it rebuilds spectra that standard search engines can use, and it outperformed single-dimension approaches on the authors' datasets.

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