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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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Medtronic Expands Two Insulin Pump Recalls, Including One Over Cybersecurity Concerns

XTalks

Medtronic has expanded a Class I recall of remote controllers used with the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps over potential cybersecurity risks. The medtech giant has also expanded another Class I recall of the retainer rings on its 600 series insulin pumps.

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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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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.

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Roche Invests $5.3B in Zealand’s Petrelintide, an Obesity Drug Candidate

XTalks

Amylin, a hormone co-secreted with insulin, plays a key role in regulating appetite by enhancing leptins effects the hormone that signals fullness after eating. Petrelintide, Zealand Pharmas long-acting amylin analog, is currently in Phase II clinical development and is designed for once-weekly subcutaneous injections.

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GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic

XTalks

GLP-1 receptor agonists, or incretin (metabolic hormones) mimetics, are analogs of the GLP-1 peptide hormone that binds to the GLP-1 receptor to regulate blood sugar levels by boosting insulin secretion. dependent insulin secretion and suppression of glucagon release. What Are GLP-1 Agonists? mediated glucose?dependent

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Rybelsus (semaglutide) New Label Update Allows for Early Use in Type 2 Diabetes Treatment

XTalks

The body becomes resistant to insulin and can no longer use glucose properly as a fuel, so glucose begins circulating in the bloodstream and may lead to problems with the circulatory, nervous and immune systems. Often, diabetes medication or insulin therapy are used as management tools.

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