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The FDA extrapolates from acetaminophen and oral contraceptive PK data

Small-molecule drugs with large patient populations and simple manufacturing profiles represent the clearest opportunities

As of 2024, the FDA finalized action placing ipamorelin on the list of bulk drug substances that cannot be used in compounding under Section 503A (traditional pharmacies) or 503B (outsourcing facilities)

The peptide component of MEDI4166 has been extensively optimised to provide lasting glucose and weight control that is able to better match the antibody PK in combination with a reduced GLP-1R potency and a favourable manufacturability profile