Though differences in timing and design of pediatric oncology trials within U.S. and Europe regulatory frameworks may make harmonization of trial requirements impossible, they should be seen as opportunities to expand understanding of drug development in the field, FDA said at an April 16 meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
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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.’
A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.
Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.
The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.
