have a question, issue or just some feedback for us? we're here for you.

what can we help you with?

let us know how we can help

DISCLAIMER

The information and materials accessed through or made available for use on any of our Sites, including, any information about diseases, conditions, treatments, or medicines, are for informational purposes only. The Content is not intended to be and is not a substitute for professional medical advice, diagnosis, or treatment, and your participation on our Sites does not create a healthcare professional-patient relationship. You should consult a doctor or other qualified health care professional regarding any questions you have about your health or before making any decisions related to your health or wellness. Call your doctor or 911 immediately if you think you may have a medical emergency.

compose your message

to*

from*

subject

message

message sent

email sent successfully

suggest a poll

you must have an account to suggest polls.

join now

rareLife solutions 606 Post Road East #397 Westport, CT 06880
You are receiving this because you have an account on www.oneSMAvoice.com
If you'd like to unsubscribe and stop receiving these emails click here

Trusted Resources: News & Meetings

Latest announcements and gatherings

Clinical Trial and Research
Business
People
Spotlight
Happenings

Back to News & Meetings / Clinical Trial And Research

FDA Lifts Partial Clinical Hold on Novartis’ SMA Drug Programme

The US Food and Drug Administration (FDA) has lifted the partial clinical trial hold on Novartis’ intrathecal (IT) OAV-101 (AVXS-101) programme for patients with spinal muscular atrophy (SMA).

The latest decision comes after the FDA analysed data from the company’s nonclinical toxicology study in non-human primates that addressed all detected issues, including questions related to dorsal root ganglia (DRG) injury after IT injection.

With the FDA approval and input, along with guidance from the European Medicines Agency (EMA), Novartis intends to commence the Phase III STEER trial to assess the clinical efficacy, safety and tolerability of a single IT dose of OAV-101 in SMA patients aged two to 18 years.

FDA Lifts Partial Clinical Hold On Novartis’ SMA Drug Programme

Source: https://www.clinicaltrialsarena.com/news/fda-novartis-sma-clinical-hold/

Discuss in Social Wall

Share to rareTeam

Bookmark

send a message

send to:
subject:
message:

edit tags:

Reset password

Mobile

Enter Phone Number

Enter the code

Almost done!

We just send a four digit code to your mobile number. Enter it here to login!

Didn't receive the code?Re-send
Or login in with your password instead

password changed successfully!

please log in with your email address and new password.

your activation key expired

this confirmation key has expired. please try to log in again or resend confirmation email.

confirmation email sent

a confirmation email has been sent to your inbox. click the link in the email to activate your account.
can't find the email? be sure to check your spam folder.

password reset email sent

an email has been sent to you with a link to reset your password.
can't find the email? be sure to check your spam folder.

If you are a doctor or other qualified health care professional, you should not offer any medical advice or treatment on our Sites, nor should you allow the content of our Sites to substitute for your own medical judgment. Please thoroughly review the information provided on our Sites before deciding whether any of the products, services, or treatments therein are right for you or others.

your account is now activated!

Join the community

This feature is only available to members.

Already have an account? Log in.

I have read and understand the oneSMAvoice privacy policy and terms of use.

Almost done!

We just sent a four digit code to your mobile number. Enter it here to log in!

Please Wait!!!

Didn't receive the code? Re-send
Or log in in with your password instead

Log in

This feature is only available to members.

Don't have an account? Click here to register.

you haven't confirmed your email address yet. resend confirmation email

Forget your password? Reset here.

or register with

Need to get in touch?

Trusted Resources Home

Education

People & Places

News & Meetings

Videos & Visuals

FDA Lifts Partial Clinical Hold on Novartis’ SMA Drug Programme

Related Content

Powered by

Trusted Resources Home

Education

People & Places

Community Center

News & Meetings

Videos & Visuals

Trusted Resources: News & Meetings

Latest announcements and gatherings

FDA Lifts Partial Clinical Hold on Novartis’ SMA Drug Programme

Related Content

Powered by

In partnership with