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Milestones In Basket Trials: Novartis' Ambitious SIGNATURE Program

 
• By Bridget Silverman and Emily Hayes

Novartis' tissue-agnostic SIGNATURE trial uses eight of the company's drugs in an ambitious set of Phase II protocols that will be an important test of whether basket trial designs are useful in corporate oncology R&D programs.

Novartis AG's SIGNATURE trial is the most extensive company-sponsored basket trial yet attempted, testing eight of the company's drugs in patients selected for a wide array of biomarkers in a histology-independent study.

Roche's VE BASKET trial may be the first significant basket trial from a sponsor company, but it limited its...

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• By Vibha Sharma

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Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
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