GLP-1
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate an evolving mindset toward treating obesity as a chronic disease.
While Kallyope’s drugs are mechanistically unique, the biotech is competing in a crowded space, with other therapies that appear to elicit superior weight-loss.
As high prices and supply issues drive consumers to alternative markets for GLP-1s, physicians aren’t too interested in using these therapies to treat conditions like heart disease risk that have existing cheap standards of care.
As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.
The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage.
Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers.
The data, published in JAMA Psychiatry, add to the growing body of evidence supporting the use of GLP-1 receptor agonists for addictive disorders.
Biogen and Eisai have spent much of Leqembi’s launch convincing physicians and patients that it’s safe to treat Alzheimer’s disease. With patients now hitting the 18-month mark of treatment, the conversation is finally shifting to efficacy.
From revenue to R&D investment, Novo and Lilly and their mega-blockbuster weight loss drugs Zepbound and Wegovy have moved into a new pharma stratosphere, far eclipsing their rivals.
Compounding pharmacies aren’t the only makers of off-brand versions of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The situation is causing the FDA regulatory headaches and, more seriously, posing potential risks to the public.
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