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

New EU Submissions For Pfizer’s Lorlatinib, Teva’s Fremanezumab - And A CV Filing For Canakinumab

Executive Summary

New products submitted for evaluation by the European Medicines Agency include Pfizer’s lorlatinib for lung cancer, Teva’s fremanezumab for migraine, and Shionogi’s lusutrombopag for thrombocytopenia. An already authorized drug, Novartis’s canakinumab, has been filed for a new use: reduction of cardiovascular risk.

You may also be interested in...



Teva On Tenterhooks Over Fremanezumab As Celltrion Gets CRLs

The FDA is not approving two biosimilars from Teva and Celltrion over concerns about the latter's facility, leading to more speculation that approval of the Israeli firm's potential migraine blockbuster, manufactured at the same plant, may be delayed.

Pfizer’s Dacomitinib And More Biosimilar Hopefuls Among New EMA Filings

There are eight new entries to the list of marketing applications filed with the European Medicines Agency, including submissions for more versions of Amgen’s Neulasta (pegfilgrastim), and a second biosimilar of Roche’s Avastin (bevacizumab).

EU CHMP Finalizes Outstanding Issues On Aimovig And Symproic

EU regulators meeting in London are finalizing the outstanding questions they have for companies whose products are approaching the final stages of the approval process.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1128360

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