General Biotechnology

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” for drug companies is under unprecedented threat. The recent shifts in regulatory rigor, coupled with the rise of “label-plus” liability strategies, are fundamentally…

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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 decades of experience, predicting the precise moment when a blockbuster drug’s patent protection will expire remains one of the industry’s most elusive challenges. The so-c…

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