Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

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
My View
Tags:
Europe Review Pathway Regulation

EU Accelerated Assessment Tracker

Will Novartis's Capmatinib Be Fast-Tracked Once It Is Filed?

  • News
  • Maureen Kenny
    Maureen Kenny

Executive Summary

Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.

You may also be interested in...



Gilead’s Trodelvy To Test UK Innovative Drug Pathway

The cancer drug is also to undergo an accelerated assessment by the European Medicines Agency.

AstraZeneca & Amgen Seek EU Fast-Track For Severe Asthma Drug

Tezepelumab was among four products that the European Medicines Agency most recently considered for review under its accelerated assessment mechanism.

First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod

New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.

Table

View full table

Related Content

Pink Sheet
Pink Sheet
Pink Sheet
Pink Sheet

Topics

Related Companies

Tags:
Europe Review Pathway Regulation
Latest Headlines

Pink Sheet Podcast: Adcomm Rejects NurOwn For ALS, FDA In Shutdown Mode, Limited Price Negotiation Savings

Increase In Subpar Pharmaceutical Repacking Draws US FDA Attention

Regulatory Flexibility: BrainStorm’s Problematic NurOwn BLA May Be A Bridge Too Far For US FDA

And Then There Were 19: NurOwn Adcomm Loses Temporary Voting Member To Last-Minute Recusal

See All
UsernamePublicRestriction

Register

PS144142

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

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