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AbbVie snags priority review, breakthrough for HCV combo

 
• By Donna Young

The FDA has granted a priority review to AbbVie's new drug application for its all-oral, interferon-free, two direct-acting antiviral (2-DAA) treatment regimen consisting of the fixed-dose combination of ombitasvir, paritaprevir and ritonavir (OBV/PTV/r) with ribavirin (RBV) as a treatment for adults with chronic genotype 4 hepatitis C virus (HCV).

The FDA has granted a priority review to AbbVie's new drug application for its all-oral, interferon-free, two direct-acting antiviral (2-DAA) treatment regimen consisting of the fixed-dose combination of ombitasvir, paritaprevir and ritonavir (OBV/PTV/r) with ribavirin (RBV) as a treatment for adults with chronic genotype 4 hepatitis C virus (HCV).

AbbVie's partner Enata Pharamaceuticals, whose lead protease inhibitor paritaprevir is part of the 2-DAA regimen, revealed the combo product also...

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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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Top 10 Drugs Q1 2025: Keytruda Dominates; Mounjaro Climbs

 
• By Eleanor Malone

Lilly’s Mounjaro for diabetes rose from sixth to third position among the top-selling drugs in the first quarter of 2025, Rival Ozempic retained second position and Merck & Co’s immuno-oncology blockbuster Keytruda stayed far ahead.

Skyhawk Looks To Soar With Huntington’s Hope

 
• By Kevin Grogan

Oral RNA splicing modulator has gone into a Phase II/III trial

BIO Notebook: MFN Pricing, Next-Gen Obesity R&D, FDA’s Rare Disease Hub & Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.