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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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In an interview, chief commercial officer Tolga Tanguler gave some ideas of what to expect as the company prepares to launch the drug for ATTR-CM in Europe.

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Sumitomo Parkinson’s Filing A Pivotal Moment For Japan’s iPSC Ambitions

 
• By Lisa Takagi

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HHS mRNA Vaccine Wind-Down Has Limited Impact (And One Contract Isn’t Even mRNA)

 
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The news will have a big impact on pandemic preparedness but less immediate financial impact. Tiba Biotech was even “caught off guard” by its inclusion in the department’s culling of mRNA vaccine projects under BARDA, as its project was neither a vaccine nor mRNA-based.

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