Checkpoint Therapy’s Second Act: Hope, Hype, or Hard Truths?

Introduction A hallmark of cancer is the ability to evade or subvert immune recognition and response through a range of countermeasures such as altered tumor antigen expression, the recruitment of...
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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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Skin in the game: targeted dermatology drug development

Intro Dermatology, once a therapeutic category largely served by emollients, topical corticosteroids and small molecule immunosuppressants, is an increasing focus of targeted drug development. First...
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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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Extracellular vesicle (EV) therapeutics: good things in small packages

Extracellular vesicle (EV) therapeutics: good things in small packages Once considered simply as byproducts of cellular recycling and waste management, extracellular vesicles (EVs) have become the...
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Disease Indication Strategy for Anti-Fibrotic Drugs

Introduction: Anti-fibrotic drug candidates, prior to entering clinical development, often have a mechanism of action that may be beneficial for treatment of multiple diseases. Early strategic issues...
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Obesity: Beyond Getting Slim Quick & GLP-1s

Looking Beyond GLP-1s Currently, much of the pharmaceutical industry and up to a quarter of the population of the developed world are captivated by get-slim-quick drugs known as GLP-1 agonists, and...
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What’s Bugging You? The Next Chapter for Microbiome Drugs

Depending on your perspective, live biotherapeutic products (LBPs) are either a promising, newly emergent class of therapeutic agents that utilize live microorganisms to prevent or treat various...
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Planning for Pharma Partnering

It's never too early to start For biotechs developing an asset for a pharma partnership, it’s crucial to consider the key deal-success ingredients, in the eyes of a future pharma partner, well in...
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