"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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Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.