GDUFA Report Sheds Light On Effectiveness And Uptake
The latest GDUFA science and research findings have been reported by the FDA.
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The US Supreme Court has lifted a stay on document discovery in a multi-state lawsuit in which dozens of generics companies – including Teva, Mylan and Pfizer – are accused of price fixing. The ruling will allow a swathe of documents to be released in what Connecticut’s attorney general has said is potentially “the largest cartel case” in US history.
Daraprim, which saw its price jacked up by 4,000% by former drug company executive Martin Shkreli, now has a competitor with the US Food and Drug Administration’s approval of the first generic version of the nearly seven-decade-old drug used to treat a life-threatening parasitic infection known as toxoplasmosis.
US generics company Akorn, which has been struggling since Germany’s Fresenius walked away from a $4.3bn merger three years ago, plans to put itself up for sale under an extended standstill agreement with lenders.