Biomarkers Consortium Launches Adaptive Trial To Test Targeted Breast Cancer Drugs
• By Pharmaceutical Approvals Monthly
The newly launched I-SPY 2 trial will put into practice many ideas about adaptive trial design and the use of biomarkers for patient selection, and it could herald the coming of a new model of drug development.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.