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The Pulse of the Pharmaceutical Industry

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FDA flags risks from AbbVie, Gilead, Merck hepatitis C drugs to certain patients

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.

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Liver disease related to obesity and diabetes rising in U.S.

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.

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AbbVie’s Maviret approved by European Commission as shorter, 8-week, once-daily option

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.

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Gilead to separate Kite cell therapy unit

Gilead Sciences Inc. said Kite Pharma Inc., the cancer-focused cell therapy company acquired in 2017, will become a separate business unit.

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AbbVie’s Mavyret Approved for Hep C in Pediatric and Adolescent Patients

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.

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Gilead experimental NASH drug fails another study

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.

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AbbVie’s 2018: Revenues Up, Earnings Down

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.

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AbbVie’s Mavyret Shows Sky-High Hep C Cure Rates

Chicago-based AbbVie announced new data for Mavyret (glecaprevir/pibrentasvir), a pan-genotypic treatment for chronic HCV in treatment-naive patients with compensated cirrhosis.

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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.

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U.S. court upholds dismissal of $200 million Merck verdict against Gilead

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.

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