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This includes people with: Pernicious anaemia (autoimmune destruction of intrinsic factor-producing cells), typically requiring lifelong IM injections Crohn's disease or surgical resection affecting the terminal ileum Coeliac disease causing malabsorption (may improve with gluten-free diet) Chronic pancreatitis reducing enzyme availability needed for B12 release Vegans and strict vegetarians need reliable B12 sources through fortified foods or supplements, as plant-based diets contain negligible amounts of active B12
Organizations involved: sponsor pharma/biotech, clinical research organizations (CROs) running trials, clinical sites and investigators, central labs, data monitoring boards, regulatory agencies (FDA, EMA, PMDA, NMPA, CDSCO), and regulatory consultants for dossier preparation Patient Support & Services After approval, the focus shifts to market access, pricing, and reimbursement negotiations with healthcare payers
While these synthetic GLP-1 agonists have demonstrated remarkable efficacy in clinical trials, they are associated with a range of side effects, including common gastrointestinal issues such as nausea, vomiting, diarrhea, and constipation, which are often dose-dependent (Kommu S et al., 2025
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