Pink Sheet is part 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

Drug Safety: Sequential Surveillance Helps Regulatory Decision-Making, But Hurt By Premature Specification

Executive Summary

US FDA and academic researchers say unknowns related to certain product aspects make it difficult to form a hypothesis in formal sequential surveillance designs.

You may also be interested in...



Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data

After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.

Xpovio Clinical Development Timeline

Chronicle of the development and review of Karyopharm's Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.

Xpovio's US FDA Review: A Primer On How (Not) To Submit Real-World Data

Karyopharm included a real-world data study to support its Xpovio NDA, but the US FDA deemed the study inadequate for an overall survival comparison to the pivotal STORM trial.

Topics

UsernamePublicRestriction

Register

OM010563

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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