In Vivo 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

FDA Leader: We Need To Remove Surprises From Gene Therapy Development

Executive Summary

Embattled gene therapy companies will take comfort from desire of FDA and EMA help smooth the process of bringing the novel treatments to market.

You may also be interested in...



VBL Therapeutics Switches Tack After Pivotal Gene Therapy Ovarian Cancer Fail

The Israeli firm’s gene therapy asset has disappointed in an advanced ovarian cancer study, leaving experts skeptical of its potential in other tumors and the company turning to an earlier program.

Sanofi/Sobi’s Next-Gen Factor VIII Therapy BLA Heats Up Biotech-Driven Hemophilia Arms Race

Sanofi/Sobi’s efanesoctocog is in line for US FDA action three months after CSL/uniQure’s gene therapy user fee goal, while BioMarin’s Roctavian resubmission and Novo Nordisk’s concizumab are waiting in the wings.

Micro-Dosing Gene Therapy: A Recipe For Success?

Utilizing the genetic overlap between frontotemporal dementia and amyotrophic lateral sclerosis, AviadoBio is seeking to develop gene therapies which can stop both these devastating diseases in their tracks using novel delivery techniques.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

IV125102

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