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STAT+: Eli Lilly opens a new legal front in its battle against compounded GLP-1s

STAT

To date, Lilly and its rival, Novo Nordisk, have filed dozens of suits against numerous companies involved in compounding versions of semaglutide and tirzepatide, the obesity and diabetes drugs known as GLP-1s. District Court for the Northern District of California.    Continue to STAT+ to read the full story…

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Compounding pharmacies rebut Novo’s FDA petition

STAT

Also, compounding pharmacies fire back at Novo Nordisk for its assertion that GLP-1 drugs are too difficult to compound. Lots today on GLP-1s: First we see tirzepatide outperforming semaglutide in a head-to-head study in obesity. Also, a Michael Gilman company pivots and more. Read the rest…

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STAT+: FDA confirms shortage of weight loss drug tirzepatide is over, gives compounders a grace period

STAT

The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.

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STAT+: The end of compounded GLP-1 copies leaves many patients in a ‘lose-lose’ position

STAT

The explosion of compounded GLP-1 offerings over the past two years is coming to an end, and many patients are left with no good options.  Businesses are changing prescriptions, mixing in additives, or encouraging stockpiling of existing compounded products. Some have disappeared altogether.

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STAT+: Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list

STAT

The move means that patients will no longer have access to cheaper versions from compounding pharmacies. Due to ongoing shortages of the Lilly drugs, compounding pharmacies were permitted to make copies that sold for substantially less.

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STAT+: Court ruling opens door to FDA action against Ozempic compounders

STAT

Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy. Compounding pharmacies are legally allowed to make versions of branded treatments if the drugs are deemed to be in shortage by the FDA.

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STAT+: Novo Nordisk’s Ozempic and Wegovy, long in shortage, are now listed as available by FDA

STAT

Over the past two years, patients seeking treatment have been turning to compounding pharmacies, which make cheaper copies of branded treatments and are legally allowed to do so only when the branded treatments are listed on the FDA’s shortage list.    Continue to STAT+ to read the full story…