The U.S. Food and Drug Administration identified 63 cases of worsening liver function in certain patients taking hepatitis C medicines made by drugmakers Merck & Co. Inc., Gilead Sciences Inc. and AbbVie Inc.
GlaxoSmithKline exercised an option to license Ionis Pharmaceuticals’ antisense medicines for people with chronic hepatitis B virus infection following positive Phase 2 results.
The only liver disease becoming more widespread in the U.S. is one driven by obesity and diabetes – NAFLD – even as other liver disorder types linked to drinking or hepatitis become less common.
AbbVie announced that the European Commission granted marketing authorization for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C patients with genotype 1, 2, 4, 5, and 6 infection.
A collaboration and license deal was inked with Gilead Sciences Inc. to develop and market a long-acting injectable HIV therapy using Durect Corp.’s SABER technology.
VBI Vaccines Inc. said a late-stage study testing the company’s hepatitis B vaccine against GlaxoSmithKline’s Engerix-B met the main goals.
Gilead Sciences Inc. said Kite Pharma Inc., the cancer-focused cell therapy company acquired in 2017, will become a separate business unit.
The U.S. FDA approved AbbVie’s Mavyret for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older during 2017.
Gilead Sciences Inc.’s experimental drug aimed at treating a type of fatty liver disease known as NASH failed to meet the main goal of a late-stage study, two months after failing another clinical trial.