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

Zykadia Expedited Timeline Challenged By Late-Breaking GMP Concern

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

CDER Director Woodcock was quickly consulted about a manufacturing concern at a foreign site that emerged shortly before FDA’s target action date for Novartis’ ceritinib NDA as the agency strove to avoid delaying approval of the “breakthrough” lung cancer therapy.

You may also be interested in...



Review Of Reviews: Drug Review Profiles 2014

Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.

Review Of Reviews: Drug Review Profiles 2014

Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.

Same-Day BLA Filings Show Pfizer Has Gained Ground On Novartis In Meningitis B

Both companies have “breakthrough” therapy designations from FDA and both announced BLA filings on June 17, but Pfizer’s earlier completion of the rolling submission could give it an edge in the race to launch a meningitis B vaccine in the U.S.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS005752

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