Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

TKT Replagal Surrogate Data Should Be Reworked For Accelerated Approval

Executive Summary

Transkaryotic Therapeutics' Replagal histologic data should be reevaluated to determine whether they may satisfy a surrogate endpoint for accelerated approval in Fabry Disease, members of FDA's Endocrinologic & Metabolic Drugs Advisory Committee said Jan. 14
Advertisement

Related Content

Replagal Advisory Committee Will Include Closed Door Session On Manufacturing
TKT Hopes To Break Even In 2006 Following Hunter Syndrome Therapy BLA
TKT Hopes To Break Even In 2006 Following Hunter Syndrome Therapy BLA
TKT Replagal Decision On New Trial Expected In Four Months
TKT Replagal Decision On New Trial Expected In Four Months
Fabrazyme Approved; FDA Weighing What Confirmatory Data Will Be Needed
Genzyme Ready To Launch Fabrazyme And Aldurazyme; User Fee Dates Near
Genzyme Expects Fabrazyme Approval Before Confirmatory Trial Completion
Replagal Antibody Response Should Be Studied Postmarketing, Cmte. Says
Replagal Antibody Response Should Be Studied Postmarketing, Cmte. Says
Advertisement
UsernamePublicRestriction

Register

PS041139

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel