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Janssen gains FDA nod for HCV protease inhibitor Olysio

 
• By Donna Young

The FDA gave Johnson & Johnson subsidiary Janssen Therapeutics approval on 22 November to market Olysio (simeprevir) as a treatment for chronic hepatitis C virus (HCV) as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin.

The FDA gave Johnson & Johnson subsidiary Janssen Therapeutics approval on 22 November to market Olysio (simeprevir) as a treatment for chronic hepatitis C virus (HCV) as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin.

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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