Is Gilead’s Selonsertib for NASH Dead?

Title: Is Gilead’s Selonsertib for NASH Dead? Author: Peter G. Traber, MD Date: 02/12/2019 Introduction The search for an effective therapy for NASH with advanced fibrosis/cirrhosis suffered a major...
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Orkambi UK - Sound and Fury

By Anthony Walker, PhD, Managing Partner There’s a lot of sound and fury about Orkambi in the UK. Following a rejection from NICE, Vertex and NHS England have not been able to reach terms and the...
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Why Every Biotech Needs a Scouting Function

Title: Why Every Biotech Needs a Scouting Function Author: Chris Owens, PhD What is asset scouting? Simply put, it is a search to identify and evaluate pharmaceutical assets or partners for...
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microRNAs as drug targets

microRNAs as drug targets Saadia Basharat, PhD, Senior Consultant microRNAs (miRNA) are small noncoding RNAs that regulate the expression of multiple target genes by either blocking the translation...
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Infographic: Britain crashes out of favor with US pharmaceutical executives

Britain crashes out of favor with US pharmaceutical executives The biotech industry is a pillar of the knowledge economy, with governments around the world investing heavily to attract capital and...
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NASH Surprises and Interpretation of Clinical Trials

Title: NASH Surprises and Interpretation of Clinical Trials Author: Peter G. Traber, MD Introduction 2019 will usher in a new chapter in NASH drug development with data reported on the first phase 3...
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Pharma Defying Gravity – How Much Longer?

Anthony Walker, PhD, Managing Partner, Alacrita Consulting
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Routes to European Commercialisation in Europe

Title: Routes to Commercialisation in Europe Author: Anna Casse, Managing Partner Abstract In the past it was not extraordinary for US biotech companies to develop drugs in the US and to launch them...
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Agencies Clarify NASH Endpoints—But Don’t Harmonize

Title: Agencies Clarify NASH Endpoints—But Don’t Harmonize Author: Peter G. Traber, MD The FDA and EMA have recently published very similar clinical trial endpoints for pre-cirrhotic NASH, with one...
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Industry Strategies for NASH Combination Therapies

Introduction: Many have commented that drug combinations represent the future of NASH therapeutics. As indicated by Pfizer’s recent announcement, large pharma companies are putting efforts toward the...
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Is Rapid Reversal of Liver Fibrosis Possible?

Title: Is Rapid Reversal of Liver Fibrosis Possible? Author: Peter G. Traber Introduction Treatment of liver fibrosis is a major focus of drug development with multiple companies examining a variety...
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NASH Cirrhosis Space Poised to Heat Up

Title: NASH Cirrhosis Space Poised to Heat Up Author: Peter G. Traber, MD NASH cirrhosis is the most advanced classification of fibrosis progression in fatty liver disease. Results of clinical trials...
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