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STAT+: Novo asks FDA to bar compounders from making Ozempic copies

STAT

Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make. The FDA still has to make a decision on whether to officially place semaglutide on the lists.

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STAT+: Pharmalittle: We’re reading about Novo targeting compounded obesity drugs, an Amgen ‘at risk’ launch, and more

STAT

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. … Novo Nordisk has asked the U.S.

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Does Blue Cross Blue Shield cover Zepbound?

The Checkup by Singlecare

When Zepbound is covered, prior authorization is usually required, and the patient may need to meet clinical requirements such as a BMI of 30 or more or a BMI of 27 or more with a comorbid condition like hypertension or Type 2 diabetes, and documented weight management efforts like a low-calorie diet and increased physical activity.

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Does Blue Cross Blue Shield cover Mounjaro?

The Checkup by Singlecare

Compounded drugs aren’t usually covered by insurance because they aren’t FDA approved, and the FDA has shared its concerns about compounded GLP-1s like Mounjaro, such as low-quality ingredients, contaminants, or incorrect dosing. You can also log in to your health insurance portal to access policy documents. mL of 5 mg/0.5

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STAT+: Pharmalittle: We’re reading about a Zepbound-Wegovy faceoff, compounders slamming Novo, and more

STAT

But documenting the differences between Zepbound and Wegovy in a rigorous way might allow Lilly to make marketing claims about Zepbound’s superior efficacy.   A trade group for compounding pharmacies slammed an attempt by Novo Nordisk to convince the U.S.

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Does Aetna cover Mounjaro?

The Checkup by Singlecare

This means the Aetna plan will only cover Mounjaro if the patient’s medical provider provides documented proof that the person meets certain requirements, such as a diabetes diagnosis or concerning blood glucose levels. Prior authorization: Some, if not all, Aetna plans require prior authorization for Mounjaro.

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FDA accepts Outlook Therapeutics’ BLA for wet AMD treatment

Pharmaceutical Technology

On receiving approval, the treatment is expected to replace the requirement to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for wet AMD treatment. It is also developing registration documents for approvals in Europe, with submission expected in the fourth quarter of this year.

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