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How AI will reshape pharma by 2025

Drug Target Review

However, recent breakthroughs in AI, such as predictive modelling, clinical trial optimisation, and personalised medicine, have demonstrated its potential. We spoke with Aaron Smith, a mathematician-turned-machine learning scientist and the founder of Unlearn , a company leading the charge in applying AI to optimise clinical trial efficiency.

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. New Drug Application (NDA) : Needed for marketing approval of new drugs.

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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.

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Phase 3 Trial of Ifinatamab Deruxtecan Begins in Advanced Prostate Cancer

The Pharma Data

Discovered by Daiichi Sankyo, I-DXd is being co-developed with Merck (known as MSD outside of North America) as part of a broader strategic collaboration between the two companies. Building on Early Clinical Success The Phase 3 IDeate-Prostate01 trial is based on encouraging results from the earlier IDeate-PanTumor01 Phase 1/2 study.

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Redefining Acceleration of the Drug Development Journey

PPD

As companies undertake these steps, they increasingly rely on supply partners like Thermo Fisher who can address challenges in real time, helping maintain the highest levels of quality throughout the process without losing time or momentum.

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Future-proofing drug development with GenAI

Drug Target Review

It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinical trials. Because LLMs are trained on extensive, internet-scale datasets, they can learn to identify contexts linking words and language.

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The future of CNS drug development: signs of real progress

Drug Target Review

This heterogeneity also affects the ability to produce consistent results in clinical trials, as study groups sharing the same symptoms and disease progressions are hard to find. These gaps in knowledge can lead to a trial-and-error approach to clinical trials, which can result in high failure rates.