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Executive Summary

Drug regulation is entering a period of significant transformation.

For decades, pharmaceutical regulation has relied on established scientific standards, structured clinica...


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Executive Summary

Artificial intelligence is moving from experimentation to infrastructure.

Pharmaceutical companies have spent the past several years testing AI across drug discovery, clinical trials, medical affai...


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Key Trial Breakthrough in Skin Cancer

The personalized mRNA cancer vaccine developed by Merck & Co. and Moderna has proven to extend patients’ recurrence-free survival (RFS) when combined with Keytruda for patients with high-risk skin cancer. The phase 3 victory helps put the partners in a position to apply for accelerated approval.

INTerpath-001 invo...


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The U.S. Food and Drug Administration (FDA) has issued warning letters to Aurobindo Pharma’s sterile injectables and oncology subsidiary Eugia Pharm...


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Novo Nordisk has started a new late-stage clinical study to evaluate lower maintenance doses of its oral obesity treatment Wegovy, according to information pos...


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