Scienmag

JANUARY 4, 2022

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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XTalks

JULY 3, 2023

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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Scienmag

JULY 19, 2022

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 ? They have revealed that zinc (Zn) plays a crucial role in PSC potentiation.

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Fierce Pharma

JULY 11, 2024

The FDA has slowed the roll for Novo Nordisk, rejecting its once-a-week insulin icodec for patients with Type 1 and Type 2 diabetes. regulator made "requests related to the manufacturing process and the type 1 diabetes indication," which the company said it does not expect to remedy by the end of this year.

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BioPharma Reporter

NOVEMBER 21, 2022

Oramed Pharmaceuticals, a company focused on the development of oral drug delivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate.

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Pharma in Brief

AUGUST 9, 2021

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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Camargo

OCTOBER 14, 2020

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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XTalks

OCTOBER 7, 2024

The US Food and Drug Administration (FDA) has issued a Class I label for the recall of Medtronic’s MiniMed insulin pumps. The devices are used to regulate blood glucose levels by delivering precise amounts of insulin based on readings from an integrated continuous glucose monitor (CGM).

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Scienmag

DECEMBER 3, 2020

Researchers from the University of Copenhagen and biotech firm Gubra have developed a new insulin molecule that will make blood sugar regulation both easier and safer for those with type 1 diabetes Everyday life for the more than 46 million people around the world who suffer from type 1 diabetes could become much easier and […].

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BioPharma Reporter

FEBRUARY 16, 2022

Multiple pharma R&D teams are seeking to transform how diabetes treatment is managed.

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XTalks

JULY 14, 2023

s Tandem Mobi insulin pump for individuals six years of age and older with diabetes. Tandem has dubbed The Mobi to be the world’s smallest insulin pump. The Tandem Mobi is designed for use as part of an automated insulin delivery (AID) system. Users can also self-administer bolus insulin doses manually.

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Scienmag

SEPTEMBER 29, 2021

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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Scienmag

JUNE 13, 2022

Researchers at Karolinska Institutet in Sweden show how a molecule that they have identified stimulates the formation of new insulin-producing cells in zebrafish and mammalian tissue, through a newly described mechanism for regulating protein synthesis. The results are published in Nature Chemical Biology.

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XTalks

NOVEMBER 2, 2021

The government of Scotland has rolled out a new C-peptide test for type 1 diabetes that could help patients monitor their insulin levels with greater accuracy. The test provides information about the amount of insulin a patient has in their body, which can help determine whether they can reduce or stop taking their insulin injections.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S.

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BioPharma Reporter

APRIL 17, 2023

The South Korean company is set to create a new facility in West Virginia to house insulin manufacturing and to deliver its insulin products in the country.

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STAT News

MARCH 9, 2023

WASHINGTON — President Biden made lowering drug prices a key part of his budget with proposals to expand Medicare drug price negotiation, squeeze more rebates out of drug companies, and lower the cost of insulin for everyone with insurance. The request made Thursday also details a $7.2

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BioPharma Reporter

JULY 16, 2024

Novo Nordisk will have to fulfill requests from the FDA regarding the manufacturing process and the indication before it can receive approval for insulin icodec.

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Drug Patent Watch

JANUARY 13, 2025

Similarly, the European Medicines Agency (EMA) has been at the forefront of biosimilar regulation, with a well-established approval process in place since 2006. ” Diabetes: Addressing a Global Epidemic With diabetes affecting millions worldwide, the advent of biosimilar insulins has been particularly impactful.

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FDA Law Blog

AUGUST 12, 2021

On July 30, 2021, FDA approved Semglee (insulin glargine-yfgn), an insulin product that relies on Lantus (insulin glargine) as its reference product. So, it remains to be seen if and when interchangeable Semglee will have any meaningful effect on insulin prices in the near future.

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Medical Xpress

FEBRUARY 23, 2023

Type 2 diabetes is a chronic disease in which the body does not produce enough of the hormone insulin, which regulates blood sugar, while cells in the muscle, fat and digestive system simultaneously become less sensitive to it, absorbing less sugar from the blood stream.

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XTalks

MARCH 17, 2025

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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XTalks

JANUARY 16, 2023

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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XTalks

NOVEMBER 9, 2022

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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pharmaphorum

JULY 27, 2021

It plans to launch a mandatory cash tender offer to purchase the remaining shares in the company for the same price later and complete the acquisition entirely before the end of the third quarter – assuming it gets approval from the French financial regulator. The deal values Voluntis at around $79 million (around $95 million).

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Pharmaceutical Technology

AUGUST 31, 2022

Devices such as insulin pumps, heart pacemakers, and inhalers can track patient data in real-time and transmit to the user’s phone, an app, or their doctor, making the data immediately accessible, and often keeping the patient out of the hospital.

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Outsourcing Pharma

JULY 18, 2023

Convatec Group, a medical products and technologies company focused on chronic conditions, has partnered with Tandem Diabetes Care on a new five-inch infusion set for Tandem Mobi, the worldâs smallest durable automated insulin delivery system.

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Scienmag

MAY 4, 2021

Credit: Lin-Feng Chen A new study, published in JCI Insight, looks at how Brd4, a regulator of the innate immune response, influences diet-induced obesity. The researchers believe that Brd4 could be used as a target for obesity and insulin resistance. Approximately one-third of the adults and one in five children in the U.S.

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pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well. The next steps?

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pharmaphorum

JULY 7, 2021

Despite those concerns, an advisory committee to the regulator voted in favour of approval in May – albeit by a less than convincing 10 to 7 margin – which seemed to tip the balance in favour of approval.

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XTalks

JUNE 3, 2021

The study , published yesterday in the Endocrine Society’s Journal of Clinical Endocrinology and Metabolism , revealed that two helpings of fruit led to higher measures of insulin sensitivity than those who ate less than half a serving. Diabetes is a growing health problem globally. Keep it Fresh.

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Druggist

MAY 6, 2021

Beta-cells : cells present in the pancreas, which produce insulin. Insulin: a hormone that allows glucose (sugar) to be used for energy in the body. Lastly, metformin improves sensitivity to insulin (Wiernsperger & Bailey, 1999), which regulates body sugar levels. Metformin does not increase insulin release.

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XTalks

DECEMBER 13, 2024

Petrelintide, administered once a week under the skin, targets obesity through its action as an amylin analog, a hormone co-secreted with insulin from the pancreas. Amylin helps regulate satiety and slows gastric emptying, which can support weight loss.

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pharmaphorum

MAY 21, 2021

Arecor’s own lead product is an ultra-rapid acting insulin, which the company hopes will outperform market rivals from the likes of Eli Lilly, Sanofi and Novo Nordisk. Codenamed AT247, the product has a novel meal-time insulin formulation, which significantly accelerates insulin absorption post injection.

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XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. It’s much needed. It’s a hot area.” trillion Consolidated Appropriations Act.

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The Pharma Data

MARCH 3, 2022

Patients taking the oral blood pressure medication not only required less daily insulin two years after first diagnosis of the disease, but also showed evidence of surprising immunomodulatory benefits. Type 1 diabetes is an autoimmune disease that causes loss of pancreatic beta cells, which produce endogenous insulin.

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