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Long Wait Ahead For Novartis's Leqvio In US

German Launch In February, UK Maybe Q3

 
• By Kevin Grogan

The timeline for a US resubmission of the closely watched PCSK9-targeting cholesterol treatment could be either Q2 or Q3 and approval will depend on whether the FDA needs to make a physical inspection of an Italian facility.

delays
US patients won't be getting Leqvio any time soon • Source: Shutterstock

Any hopes for an imminent Europe-wide launch of Novartis AG's Leqvio or a speedy resolution of the issues that have held up US approval of the closely watched twice-yearly cholesterol drug have been cooled by CEO Vas Narasimhan.

Speaking as Novartis unveiled its fourth quarter and full-year 2020 results, Narasimhan addressed the surprising complete response letter (CRL) for...

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Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 
• By Anju Ghangurde

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