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538,731 Results for "leiter s compounding".
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Drug shortages
FDA Confirms Lilly’s GLP-1s Are Not in Shortage, Gives Compounders Grace Period
After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
December 19, 2024
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3 min read
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Tristan Manalac
GLP-1
Lilly Asks to Join GLP-1 Compounding Lawsuit
Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.
January 3, 2025
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2 min read
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Nick Paul Taylor
Diabetes
Novo Launches Citizen Petition to Block Compounded Victoza
In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza.
January 6, 2025
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2 min read
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Tristan Manalac
Drug shortages
Lilly’s Tirzepatide Could Land Again on FDA Drug Shortage List, Opens Door for Compounders
While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug.
October 14, 2024
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2 min read
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Tristan Manalac
Manufacturing
Lilly Pumps $3B Into Wisconsin Site as Compounders Close In on Tirzepatide
Eli Lilly is aggressively ramping up its manufacturing capacity for tirzepatide as compounding pharmacies continue to challenge an FDA decision to formally end the shortage of the obesity and diabetes drug.
December 6, 2024
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2 min read
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Tristan Manalac
Regulatory
Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
October 23, 2024
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2 min read
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Tristan Manalac
Obesity
FDA Flags Safety Risks of Compounded Versions of Novo’s Semaglutide, Reports Hospitalizations
The regulator on Friday warned healthcare providers and patients about adverse events linked with dosing errors from compounded versions of Novo Nordisk’s weight-loss and diabetes drugs.
July 29, 2024
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2 min read
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Tristan Manalac
Drug shortages
Legal Challenge Over Lilly’s GLP-1 Shortages Highlights FDA’s Post-Chevron Vulnerability
Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.
November 26, 2024
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4 min read
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Ben Hargreaves
Press Releases
Enveric Biosciences Announces New U.S. Patents Supporting EVM301 Series and EVM201 Series Compounds
December 2, 2024
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6 min read
U.S. Compounding Pharmacies Market Size to Hit USD 10.76 Bn By 2033
According to a recent report by nova one advisor, the U.S. compounding pharmacies market size was exhibited at USD 5.95 billion in 2023 and is projected to hit around USD 10.76 billion by 2033, growing at a CAGR of 6.1% during the forecast period 2024 to 2033.
May 15, 2024
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12 min read
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