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Aegerion Juxtapid Settlement Shows REMS Have Teeth: Alternate Route To Enforce Off-Label?

 
• By Cole Werble and Michael McCaughan

Who says FDA can’t bring off-label cases? They may just morph into REMS violation cases – if, that is, FDA starts using the REMS authority more often.

Aegerion Pharmaceuticals Inc.’s proposed settlement with the Department of Justice over its marketing of the homozygous familial hypercholesterolemia therapy Juxtapid includes one count related to violation of the FDA-mandated Risk Evaluation & Mitigation Strategy for the product.

The company’s May 12 announcement of a preliminary settlement with DoJ and the Securities & Exchange Commission does not get...

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Stealth Pushes for Faster US FDA Review Of Barth Syndrome Drug As Funds Dwindle

 
• By Sue Sutter

The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.