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.
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.
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.
AbbVie reported a loss of $1.83 billion for the fourth quarter of 2018. Overall revenues were up for full-year 2018, however, hitting $32.75 billion compared to $28.2 billion in 2017.
Chicago-based AbbVie announced new data for Mavyret (glecaprevir/pibrentasvir), a pan-genotypic treatment for chronic HCV in treatment-naive patients with compensated cirrhosis.
Outcome Health Announces Partnership with American Liver Foundation to Promote Updated Screening Recommendations for Hepatitis C
Outcome Health announced a partnership with the American Liver Foundation to raise awareness of liver disease, specifically hepatitis C.
A U.S. appeals court affirmed a ruling that Merck & Co. dishonestly obtained patent rights and was not entitled to collect a $200 million infringement verdict that the company won against Gilead Sciences.