KHN Morning Briefing

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New Trial Ordered In Battle Over Cholesterol Drug In Win For Sanofi, Regeneron Over Amgen

A federal appeals court reverses a sales ban on Sanofi and Regeneron's pricey cholesterol medicine Praluent. In other pharmaceutical industry news, the FDA considers looser safety protocols on compounded drugs.

Stat: Sanofi And Regeneron Score A Big Win Over Amgen In The Cholesterol Wars
Sanofi and Regeneron Pharmaceuticals won a notable victory on Thursday when a federal appeals court reversed a ban on the sale of their pricey cholesterol medicine and ordered a new trial to decide a bitter patent dispute with Amgen, their only rival in a potentially lucrative market. The appeals court permanently removed an injunction that had actually been suspended several months ago. It would have prevented Sanofi and Regeneron from marketing Praluent, a newer type of cholesterol medicine. The injunction was initially granted by a lower court after a jury last year found their drug infringed on patents held by Amgen, which sells a competing treatment called Repatha. (Silverman, 10/5)

CQ: FDA Opens Door To Loosening Drug Safety Protocols
The Food and Drug Administration says it is writing new guidance to allow so-called “office use compounding,” in which pharmacies create compounded drugs for doctors, without a prescription, for them to have at the ready in their offices. Drug compounding is a service pharmacies provide to patients who cannot take mass-produced products because of allergies or other reasons. (Zeller, 10/10)

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