1. Pink Sheet

Decompensated Cirrhosis May Be Another HCV Edge For Gilead; Bristol, J&J Still In Contention

Bristol and Johnson & Johnson have not abandoned their efforts to take a relevant place in the HCV market, although J&J isn't expected to produce triple combination data until next year.

Although great focus at the just-completed American Association for the Study of Liver Diseases conference was placed on treatment of genotype 3 infections in hepatitis C, the most difficult HCV subpopulation to cure is patients in any genotype who have decompensated cirrhosis. A recent labeling change for AbbVie Inc.'s HCV combination therapies may make this one more treatment niche where Gilead Sciences Inc. will enjoy a competitive edge.

Following an FDA safety alert Oct. 22 about liver failure and deaths in patients taking AbbVie's two HCV drugs –...

More from Drug Safety

More from Pink Sheet

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.