STAT
DECEMBER 4, 2024
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…
STAT
OCTOBER 22, 2024
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
DECEMBER 11, 2024
The deal marks a noteworthy development for Ro, which has been one of the major telehealth platforms providing compounded copies of GLP-1 obesity drugs during shortages of the branded treatments. Continue to STAT+ to read the full story…
STAT
MAY 15, 2023
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.
STAT
OCTOBER 12, 2022
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…
STAT
SEPTEMBER 20, 2023
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.
STAT
OCTOBER 6, 2023
judge dismissed its lawsuit accusing a compound pharmacy of selling versions of its Wegovy and Ozempic medicines, which are widely prescribed for weight loss and have become franchise products for the drug company. The drug maker argued the compounders were selling versions of its medicines that were never approved by the U.S.
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