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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 FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

STAT

The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs.   Most of the compounds came from commonly prescribed medications including antidepressants and statins. Continue to STAT+ to read the full story…

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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 has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

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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. That, in turn, could help the company gain market share against Novo. 

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How much does semaglutide cost per month?

The Checkup by Singlecare

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Does insurance cover compounded semaglutide? affected by a shortage).

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Why IV Automation Is Critical for Sterile Compounding

Omnicell

So why, as clinicians, are we not focused on improving the documented one in 10 inaccuracies in sterile compounded products? It’s well documented that manual processes are archaic and inaccurate, and organizations like ISMP, ASHP, and many others agree things need to change.

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Establishing quality assurance in personalised preparations

European Pharmaceutical Review

A paper published in Pharmaceutics has proposed how a personalised preparation quality assurance programme can achieve this when these products are developed in compounding laboratories. It requests that compounding laboratories adhering to the programme send samples of it. These are documented and their root cause is sought.