Epizyme, Inc.
http://www.epizyme.com/
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Latest From Epizyme, Inc.
Daiichi's Novel EZH Candidate Progresses In New Consortium Trial
Japanese major links with new partners in European consortium to progress first-in-class molecule for multiple hematological malignancies.
Finance Watch: Have Biopharma IPOs Hit Their Limit?
Public Company Edition: Three companies postponed or withdrew their offerings, but drug developers continue to pursue IPOs. Also, Biocon, BMS and Epizyme raised money through new debt, Five Prime capitalized on positive data and Synthetic Biologic engaged a strategic advisor.
Accelerated Approval Under Review By US FDA: Completing Confirmatory Trials A Focus
Top officials want confirmatory trials to finish in a ‘reasonable amount of time’ and worry that ‘if 100% of them were able to confirm, then the bar’s too high.’
Real-World Evidence: Epizyme’s Epithelioid Sarcoma Natural History Study Falls Flat At US FDA
Sponsor had hoped to use retrospective case review study as an external control arm to support regular approval of tazemetostat; US FDA not only rejected this idea, it found the study design so flawed that it did not consider the results in its efficacy assessment for accelerated approval.
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