Supplemental claim for liposomal doxorubicin has a May 21 priority review date, J&J’s Ortho Biotech unit tells “The Pink Sheet” DAILY.
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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.
