The Uncoupling of Device and Drug: A Strategic Post-Mortem of Teva v. Amneal and the New Era of Orange Book Rigor
1. Executive Summary: The End of the “Device Thicket” Era For nearly two decades, the pharmaceutical industry has operated under […]
Navigating the New IP Frontier for AI-Discovered Drugs
We stand at the precipice of a revolution in pharmaceutical research, a paradigm shift driven not by a new molecule
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The Billion-Dollar Blind Spot: Why Traditional Drug Spend Forecasts Fail and How Patent Data Provides the Missing Link
Introduction: The High Cost of Inaccuracy In the high-stakes world of pharmaceutical finance and healthcare planning, the ability to accurately
How Regulatory Affairs Masters Patent Intelligence to Architect Pharmaceutical Success
Part I: The Strategic Evolution of Regulatory Affairs in an IP-Driven Landscape In the high-stakes, capital-intensive world of pharmaceutical development,
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A Pharma Exec’s Guide to Preliminary Freedom-to-Operate Analysis
Introduction: FTO is Not a Checkbox, It’s Your Compass in the Billion-Dollar Maze In the high-stakes world of pharmaceutical innovation,
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Navigating and De-Risking the Pharmaceutical R&D Portfolio
The Billion-Dollar Gamble: Confronting the Unforgiving Realities of Pharma R&D In the world of biopharmaceutical research and development, we operate
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Mastering LOE: Expert Strategies to Predict Drug Patent Expiry and Seize Generic Market Share
Executive Summary The global pharmaceutical industry is currently navigating a period of unprecedented structural transformation. We are standing on the
The Gray Zone: How 503B Pharmacies Navigate the Intersection of FDA Regulation and Drug Patents
In pharmaceuticals 503B outsourcing facilities occupy a unique and often contentious space. Born from the ashes of a public health
More Biopharmaceutical Competition, Better Products: Evidence From Tariff Cuts
On one hand, the pharmaceutical sector is driven by a scientific and economic imperative that thrives on openness: the seamless
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