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
DECEMBER 19, 2024
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
OCTOBER 30, 2024
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…
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.
STAT
MARCH 5, 2025
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.
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…
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