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Sanofi Wins FDA Nod for Merilog, First Rapid-Acting Insulin Biosimilar

XTalks

The FDA has approved Sanofis Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar product for the treatment of diabetes. Merilog is a biosimilar to Novo Nordisks NovoLog, a widely used rapid-acting insulin aspart. Insulin, a hormone produced by the pancreas, allows glucose to enter cells for energy.

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Dopamine regulates insulin secretion through a complex of receptors, finds new study

Scienmag

Diabetes is a lifelong, chronic health condition caused by abnormalities in the body’s production and use of the hormone insulin. Research has shown that the feel-good hormone, dopamine (DA), plays a key role in how the body regulates the production of insulin.

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Salk researchers find a new route for regulating blood sugar levels independent of insulin

Scienmag

LA JOLLA—(January 4, 2022) The discovery of insulin 100 years ago opened a door that would lead to life and hope for millions of people with diabetes. Ever since then, insulin, produced in the pancreas, has been considered the primary means of treating conditions characterized by high blood sugar (glucose), such as diabetes.

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Newly Approved T1D Therapy Lantidra Could Eliminate Need for Insulin Injections

XTalks

The treatment is derived from deceased donor pancreatic cells and is indicated for patients who are unable to achieve average blood glucose levels (glycated hemoglobin) with daily insulin injections or with continuous infusion through a pump because of repeated episodes of severe hypoglycemia (low blood sugar).

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The zinc link: Unraveling the mechanism of methionine-mediated pluripotency regulation

Scienmag

Differentiation of pluripotent stem cells (PSCs) is regulated through a methionine-mediated mechanism, which has now been pinpointed by Tokyo Tech researchers. They used these insights to design a protocol to convert PSCs into insulin-producing pancreatic ? cells—a high-potential diabetes therapy.

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In the News: September Regulatory and Development Updates

Camargo

The establishment of the DHCoE is the latest of many signs that the FDA is working closely with other stakeholders to make sure that regulations keep pace with the rapid advancements in this space. Innovating regulatory approaches to provide efficient and least burdensome oversight while meeting FDA standards.

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Researchers overcome translational gap by developing novel in vivo model for the labeling of insulin secretory granule pools

Scienmag

Pancreatic beta cells produce, store and secrete insulin upon elevated blood glucose levels. However, the highly regulated process of insulin secretion, especially its molecular features and the stimuli behind this process have not yet been fully understood.

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