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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The financing dose-response curve: how much is too much?

For biotechs, how much is too much? We’re all too aware of the rate of biotech company failures at the moment. This includes venture-backed companies that have raised well in excess of $100m,...
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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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TTOs: Lost in Translation?

It's not business as usual: While the halls of biopharma partnering conferences have refilled, it is definitely not business as usual in the industry. Valuations are down sharply from their pandemic...
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Is it ever too early to consider new drug pricing strategy?

Is it ever too early to consider new drug pricing strategy?
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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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Experts and Witnesses: Two Sides of the Same Coin

It surprises, and occasionally alarms, even experienced experts familiar with undertaking due diligence on behalf of investors or corporations to realize their knowledge, skills and attributes make...
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The Rise and Rise of Antibody-Drug Conjugates

The path of the "magic bullet" Around the turn of the last century, Paul Ehrlich postulated that tailored and targeted drug delivery might be a means of treating disease1. Some eighty years later,...
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Do Price and Value Assumptions Belong in a Target Product Profile?

We often get pushback from clients about the merit of including launch price assumptions and value proposition statements in the target product profile (TPP) for early-stage development programs....
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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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