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Nanotech, gene editing used to edit cholesterol gene: U.S. study

U.S. researchers have used nanotechnology plus the powerful CRISPR-Cas9 gene editing tool to turn off a key cholesterol-related gene in mouse liver cells.

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Boehringer, MiNA Therapeutics Forge NASH Deal

Boehringer Ingelheim struck a deal targeting liver disease with MiNA Therapeutics.

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Mallinckrodt Pays $117 Million for Bay Area Biotech Ocera, Failed Liver Drug

Staines-Upon-Thames, UK-based Mallinckrodt agreed to buy Redwood City, Calif.-based Ocera Therapeutics in a deal that could hit $117 million.

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Gilead Shows Off Mid-Stage NASH Data

Gilead Sciences released results from a Phase II clinical trial of GS-0976 for nonalcoholic steatohepatitis (NASH).

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Boehringer Ingelheim partners with TARGET PharmaSolutions to Progress NASH Research

TARGET PharmaSolutions Inc. – a real-world clinical data company – and Boehringer Ingelheim International GmbH entered into a multi-year strategic partnership for TARGET-NASH, a longitudinal observational study that evaluates patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).

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Takeda Leaps Into NASH With $470M-Plus Deal With HemoShear Therapeutics

Takeda Pharmaceutical is jumping into the $40 billion market for nonalcoholic steatohepatitis (NASH) and other diseases of the liver with a $470+ million investment into Virginia-based HemoShear Therapeutics LLC.

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Deaths, Serious Liver Injury Linked to Ocaliva

The FDA warned health-care providers to stick to dosing recommendations for Intercept Pharma’s liver disease medicine Ocaliva after 19 patient deaths were reported.

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Nestle invests in microbiome diagnostics venture

Nestle is investing 20 million euros in a joint venture with Enterome SA to develop microbiome-based diagnostics for inflammatory bowel and liver diseases.

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Novartis advances with push on cancer and liver disease

Novartis’ push into oncology and liver disease, two of its treatment priorities, advanced as the Swiss drugmaker won a second U.S. breakthrough tag for its cancer gene therapy while striking a separate pact with Allergan.

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Allergan to buy Acelity’s tissue unit LifeCell

Drugmaker Allergan Plc said it would buy LifeCell – a regenerative medicine unit owned by privately held Acelity LP Inc. – for $2.9 billion in cash.

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Intercept’s liver drug wins conditional EU approval

Intercept Pharmaceuticals Inc. said its liver drug received conditional approval from the European Commission to treat patients with primary biliary cholangitis (PBC).

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Gilead Racks Up Clinical Failures in Q3 Report

Investors were not particularly happy with Gilead’s Q3 2016 report. In addition to sagging sales and revenue, it outlined a laundry list of failed clinical trials.

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Intercept’s liver drug gets conditional backing of EMA panel

Drugmaker Intercept Pharmaceuticals Inc.’s drug to treat a rare liver condition was conditionally approved an advisory committee to the European Medicines Agency.

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Gilead Terminates Ulcerative Colitis Drug Study

Following a disappointing review of interim data from a clinical study of GS-5745, an investigational anti-MMP9 antibody, Gilead said the company will halt the trial.

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Special Feature: First Year After Launch

The new generation of hep C drugs has completely changed the conversation about launches.

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2016 Annual Report: State Of The Bio Industry

The outlook remains bright due to a favorable regulatory arena, support for biopharma-friendly legislation and development incentives, expanding scientific opportunities in key therapeutic areas such as immuno-oncology, and big pharma’s continued push to obtain innovation.

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Intercept Pharma’s Liver Drug Wins Accelerated Approval by the FDA

FDA granted accelerated approval to Ocaliva, the first new medicine for primary biliary cholangitis in nearly 20 years.

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Federal Judge Reopens Gilead Case Versus Merck & Co.

Merck award may be in jeopardy after reports a former Merck scientist lied to a jury about claims he was responsible for developig hepatitis drugs Gilead was accused of infringing upon.

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FDA panel backs speedy approval of Intercept’s liver drug

An advisory panel to the U.S. Food and Drug Administration on Thursday unanimously backed the accelerated approval of Intercept Pharmaceuticals Inc’s drug to treat a rare liver condition. The drug, obeticholic acid (OCA), is being reviewed for use in patients with primary biliary cholangitis, a condition in which the body mistakes the bile ducts in […]

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FDA staff finds Intercept’s liver drug effective as monotherapy

U.S. FDA staff members on Tuesday supported the use of Intercept Pharmaceuticals Inc.’s liver drug as a monotherapy in patients unresponsive to standard-of-care.

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