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The Erosion of the Safe Harbor: Strategic Adaptation in the Era of “Label-Plus” Liability and Regulatory Rigor

In today’s rapidly evolving pharmaceutical landscape, the once-reliable “safe harbor” strategies that allowed companies to innovate and market without fear of infringing on patents are under unprecedented threat. The recent shifts in regulatory rigor, …

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General Biotechnology

The Patent Cliff Protocol: Advanced Methodologies for Forecasting Generic Drug Launches and Market Erosion

In the high-stakes world of pharmaceuticals, timing is everything. Yet, despite the critical importance of accurately predicting when blockbuster drugs will face generic competition, many industry players are flying blind—relying on outdated methods th…

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Biotechblog
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