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Latest From Tolerx, Inc.

US FDA Cancels Panel Review Of Two ‘Delinquent’ Cancer Drug Accelerated Approvals

Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.

Advisory Committees Post Market Regulation & Studies

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from, among others, Janssen, Sanofi, Boehringer Ingelheim and Mirum.

European Performance Tracker Review Pathway

From ‘Accelerate’ To ‘Confirm’: US FDA Launches Transparency Program On Cancer Drug Approvals

Oncology Center of Excellence’s Project Confirm, formerly known as Project Accelerate, is intended to promote transparency of outcomes related to cancer drug accelerated approvals; initiative includes searchable databases on the status of oncology/hematology indications.

Review Pathway Post Market Regulation & Studies

239 Days: Oncopeptides' Myeloma Drug Pepaxto Comes Off Market Just Months After Accelerated Approval

Withdrawal announcement marks shortest interval ever from accelerated approval to market removal after OCEAN confirmatory trial showed an adverse overall survival trend and US FDA said a hypothesis-generating subgroup analysis would need to be borne out in another study.

Drug Safety Review Pathway
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