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.

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

Novartis Wants More Time To Answer EMA’s Zolgensma Questions

Executive Summary

Novartis unit AveXis is one of several companies seeking extra time to address questions the European Medicines Agency has regarding their marketing applications. The company says it could get a decision on whether the product should be approved in the EU by year-end.

You may also be interested in...



Critical Juncture In Zolgensma EU Market Quest

If Zolgensma gets the thumbs up from the EMA this week, it will likely get formal EU approval within a couple of months. 

All Or Nothing: Paratek Withdraws EU Filing For Nuzyra

A month after being asked to attend an oral explanation meeting with the European Medicines Agency, Paratek Pharmaceuticals has decided to withdraw the EU marketing application for its broad spectrum antibiotic, Nuzyra. The company is one of two drug sponsors that has withdrawn an EU marketing application in October.

Novartis Says SMA Baby Death Not Due To Zolgensma

The Swiss major has new data on its SMA gene therapy which has been found not to be the cause of the death of a six-month-old patient earlier this year.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140864

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