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Citing manufacturing issue, FDA rejects Novo Nordisk's once-weekly insulin

Fierce Pharma

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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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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FTC to sue three largest PBMs over drug price practices: WSJ

Bio Pharma Dive

Antitrust regulators are set to file suit against CVS Caremark, Express Scripts and Optum Rx over how they negotiate discounts for drugs, including insulin, per the report.

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FDA delays approval of Novo Nordisk’s weekly insulin until requests are met

BioPharma Reporter

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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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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STAT+: ‘Patchy efforts’ by major insulin makers mean access lags in many poor countries

STAT News

The three companies that dominate the global market for insulin have launched various programs to expand the reach of their medicines in dozens of low and middle-income countries — but their efforts remain patchy and equitable access consequently remains out of reach, according to a new analysis.

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Oramed hits oral insulin clinical trial milestone

BioPharma Reporter

Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the worldâs first Phase 3 study of oral insulin under FDA approved protocols.

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