article thumbnail

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…

article thumbnail

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…

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

STAT

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.

article thumbnail

STAT+: In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list

STAT

The Food and Drug Administration on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, from its shortage list, and, for the time being, would not pursue regulatory action against certain compounding pharmacies making copies of the drugs. 

article thumbnail

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.

article thumbnail

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…

article thumbnail

STAT+: Lilly sues compounders, wellness centers and spas over unapproved versions of Mounjaro

STAT

As the gold rush over weight-loss drugs accelerates, Eli Lilly filed lawsuits against several compounding pharmacies, spas and wellness centers around the U.S. The drug company accused four compound pharmacies of violating state laws because those versions were not approved by the U.S.