Novartis' Inclisiran Grounded In The US By FDA Inspection Restrictions
Executive Summary
The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.
You may also be interested in...
It's Time For Novartis To Put Its Leqvio Launch Strategy To The Test
Novartis Pharmaceuticals US head Victor Bulto talks to Scrip about the launch of Leqvio; the cholesterol-lowering medicine now approved by the US FDA.
Merck's Oral PCSK9 Inhibitor Could Pose A Future Threat After Early Trial Success
MK-0616 – administered orally – reduced LDL cholesterol in patients in two early clinical trials presented at the American Heart Association Scientific Sessions.
Novartis’s Tschudin On Launches, Drug Pricing And Lasting COVID Impacts
Two years into leading Novartis' largest business unit, Novartis Pharmaceuticals president Marie-France Tschudin talked to Scrip about the US launch of inclisiran, US drug price reform and other challenges and opportunities for the industry.