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

ALS Patients Ask FDA To See Risk Their Way

Executive Summary

An FDA panel got an earful on the review and regulation of drugs for amyotrophic lateral sclerosis Feb. 25 during a public hearing convened under the agency’s plan to involve patient networks in the regulatory process, particularly where it concerns lowering barriers to drug development for ALS.

You may also be interested in...



BrainStorm’s Phase III Data Do Not Support Clinical Benefit Of NurOwn In ALS, US FDA Says

Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.

FDA Asks Genervon To Release ALS Drug Trial Data As Pressure From Patients Builds

In response to calls from patients and others about GM604, FDA issued a public statement calling on the company to release full clinical trial data for its investigative amyotrophic lateral sclerosis drug, which recently completed a Phase IIa trial.

Scientific Advances Increase Potential For Drugs To Treat ALS

New understanding of the spectrum of CNS disorders and rising interest from biotechs have revealed new targets, new biomarkers and new opportunities to treat the fast-acting and deadly neurodegenerative disease. Add to that an open stakeholder forum hosted by FDA Feb. 25 that could clarify regulatory and clinical expectations, and the tide may be turning on amyotrophic lateral sclerosis.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055155

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