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FDA drug-center staff push back on reported interim peptide plan

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Pink Sheet reported on 8 October that staff at the FDA's drug center said they will not recommend allowing temporary compounding of unapproved peptides. The report follows The Washington Post's 7 October account, citing two people familiar with the matter, of plans to allow the temporary sale of certain previously restricted peptides while new regulations are written. As of 9 October we found no published HHS or FDA notice or rule on the plan.
For research-community awareness only. Not legal advice.
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Photo: Lenharth Systems / StockSnap (CC0) / own upload
Researchers at Zhejiang University of Technology reported in the Journal of Medicinal Chemistry on 7 October SMAMP, a deep learning model that reads antimicrobial peptides as full chemical structures, so it can handle noncanonical residues and terminal modifications. Of 19 ultrashort peptides designed with the model, 13 showed antibacterial activity in laboratory tests. Two leads were also evaluated in larva and mouse models; the work is preclinical.
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Photo: Vidsplay / StockSnap (CC0) / own upload
Researchers in Shenzhen and Guangzhou reported in the Journal of the American Chemical Society on 8 October a clade of cyanobactin proteases that accept many peptide substrates while cutting only at their recognition sequence. A representative enzyme, GusA, processed complex modified peptides, removed affinity tags from proteins and was used to build phage-displayed macrocyclic peptide libraries and to label cell-surface proteins. The work involves no animal or human data.
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Photo: Matt Moloney / StockSnap (CC0) / own upload
A team in Maharashtra, India, reported in the Journal of Peptide Science on 8 October a liquid-phase method for making Fmoc-protected pseudoproline dipeptides, building blocks used in peptide synthesis, with ethanol and water in place of hazardous conventional solvents. The authors report high yields, excellent purity, a simple and scalable procedure and less solvent waste. The work is synthetic chemistry only.
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Small cyclic peptide helps antibodies cross blood-brain barrier models

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Researchers in Japan reported in Molecular Pharmaceutics on 7 October a compact, genetically encodable shuttle in which a cyclic peptide called SLS is fused to monoclonal antibodies. With a model antibody, the fusion kept its target-dependent activity, improved transport across 2D and 3D laboratory models of the blood-brain barrier and reached higher brain concentrations in mice without markedly changing levels in the blood. The work is preclinical.
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Granules names peptide contract manufacturing a growth engine in βΉ2,000 crore plan

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India Pharma Outlook reported on 8 October that Hyderabad-based Granules plans about βΉ2,000 crore of organic investment over the next three to four years. The funds are directed at complex generics, oncology, peptide contract development and manufacturing, US operations, manufacturing capacity and R&D, and the company named peptide contract manufacturing as one of four growth engines.
Curated for research-community awareness. Not medical or legal advice. All products on this site are for laboratory research use only.