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"Risk Reduction" Indications Face A Higher Bar For Approval, May Require Specialized Prescribers
Drugs that are intended to reduce the risk of cancer in a healthy population must meet a much higher bar than therapies for cancer patients, a bar that GlaxoSmithKline's Avodart (dutasteride) and Merck's Proscar (finasteride) failed to meet because they actually seemed to increase the risk of high-grade prostate cancers, FDA's Oncologic Drugs Advisory Committee said in a pair of lopsided votes Dec. 1.
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.
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The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
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The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.