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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.   Sign up  to get our biotech newsletter in your inbox. Lots today on GLP-1s: First we see tirzepatide outperforming semaglutide in a head-to-head study in obesity. Read the rest…

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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…

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STAT+: Novo Nordisk to sell obesity drug Wegovy direct to patients at lower price

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Novo Nordisk will start selling its obesity drug Wegovy directly to patients at a reduced price, following a similar move from Eli Lilly as the two drugmakers compete for market share and try to draw patients away from compounding pharmacies that have been making cheaper copies of weight loss drugs.

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

STAT

That should have prohibited compounding pharmacies from continuing to make copies of the drug, as they’re allowed to do so only when a treatment is on the shortage list.

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STAT+: FDA and large compound pharmacies settle a long-running dispute over a key list for ingredients

STAT

Food and Drug Administration and a trade group that represents large compound pharmacies have resolved a long-running dispute over the use of bulk ingredients, clearing the way for some compounded medicines to become available more quickly. Continue to STAT+ to read the full story…

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Opinion: Compounding pharmacies offer a fix for shortages of essential drugs

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At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need.

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STAT+: Pharmalittle: We’re reading about copycat weight loss drugs, ADHD prescriptions spiking, and more

STAT

Food and Drug Administration wants bulk production of copycat versions of popular weight-loss drugs to stop, but telehealth companies and compounding pharmacies that have fueled widespread use of the knockoffs have other plans , The Wall Street Journal writes. We appreciate any and all thoughts and suggestions. … The U.S.