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Novartis to manufacture anti-cholesterol drug Leqvio for US in Austria due to delay in US clearance expresspharma
July 07, 2021
US clearance stalled after the US FDA questioned "unresolved facility inspection-related conditions" at the Italian plant of Novartis supplier Corden Pharma.
US FDA declines approval for Novartis’ inclisiran expresspharma
December 21, 2020
The drug regulator cited unresolved facility inspection issues for denying approval.
Novartis analysis shows inclisiran lowers LDL-C with high consistency expresspharma
August 31, 2020
The analysis evaluated the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in two studies of more than 2,300 patients (of which 1,164 were on inclisiran).
Alnylam’s gene-silencing efforts get $2 billion Blackstone backing expresspharma
April 15, 2020
Alnylam is the first drugmaker to win US approval for a treatment using the Nobel prize-winning RNA interference (RNAi) technology and is currently developing other RNAi drugs to treat a range of conditions, including rare bleeding disorders.