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Epizyme, Inc.

http://www.epizyme.com/

Latest From Epizyme, Inc.

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.

Financing Business Strategies

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.’

Review Pathway Drug Approval Standards

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.

Drug Review Profile Real-World Evidence

Confirmatory Trial Worries Clouded Tazverik’s Accelerated Approval

Given the rarity of epithelioid sarcoma, ‘the possibility exists that this trial will not be completed,’ Division of Oncology 3 acting director Steven Lemery said in recommending approval; confirmatory trial is not expected to complete until 2029, and FDA reviewers suggest it may be underpowered to show an effect on progression-free survival. (Part 2 of our Drug Review Profile on the product.)

Drug Review Profile Drug Review
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