The Road to Approval: Navigating the Clinical Drug Development Process

The Road to Approval: Navigating the Clinical Drug Development Process The journey of a drug candidate from preclinical development to New Drug Application (NDA) approval is a critical and complex...
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Bridging the Gap: How Fractional CMOs Propel Biotech Success

Bridging the Gap: How Fractional CMOs Propel Biotech Success In the dynamic and high-stakes world of biotechnology, early-stage companies navigate a complex landscape of scientific innovation,...
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EMA Policy 0070: A New Era of Transparency in EU Regulatory Affairs

EMA Policy 0070: A New Era of Transparency in EU Regulatory Affairs The European Medicines Agency (EMA) has ushered in a new era of transparency with the reinstatement of Policy 0070 in late 2023....
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The Hidden Pitfalls of Unconscious Bias in Drug Development

Please be assured this is not a woke rant dealing with micro-aggressions or cultural stereotyping, but about something potentially much more impactful on drug development outcomes. It deals with the...
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The Perils of Misaligned Incentives: Why Drugs Fail Late in Development

Intro The journey of a drug from conception to market is notoriously fraught with challenges. In the high-stakes world of biotech and pharmaceutical development, it can be particularly damaging to...
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Maybe they should start calling it Decelerated Approval?

The FDA is proposing that a single trial could support both accelerated and full approval of oncology therapeutics. At first glance this seems to be a promising development. Though, as one reads more...
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Could COVID-19 be a catalyst for virtualizing clinical trials?

The virtualization of clinical trials has long been technically feasible, but cultural and regulatory barriers have prevented implementation. With over 1200 clinical trials worldwide being...
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Summer in Paris: NASH Update

Title: Summer in Paris: NASH Update Author: Peter G. Traber, MD Date: 07/16/2019 The Paris NASH meeting was held July 11 and 12, 2019, subtitled as an “International Think Tank” and it certainly did...
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Therapy for NASH Cirrhosis is a Distant Hope

NASH is a chronic liver disorder that results in progressive fibrosis, ultimately culminating in some patients in liver cirrhosis. In cirrhosis, the fibrotic scar tissue distorts the normal liver...
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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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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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Madrigal’s and Viking’s NASH Drugs: Who’s best in class?

Title: Madrigal’s and Viking’s NASH Drugs: Who’s best in class? Author: Peter G. Traber, MD Two companies, Madrigal Pharmaceuticals (NASDAQ: MDGL) and Viking Therapeutics (NASDAQ: VKTX), this year...
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