FDA Asks Genervon To Release ALS Drug Trial Data As Pressure From Patients Builds
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
ALS Drugs: A Long History Of Regulatory Twists At US FDA
The US FDA is set for two high-profile advisory committee meetings on potential ALS treatments before the end of 2022. Whatever the outcome, they will fit a pattern: when it comes to ALS treatments, there is very little about the regulatory process that feels routine.
ALS Patients Ask FDA To See Risk Their Way
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.
Supreme Court Seems Ready To Uphold Ruling Against Amgen’s Anti-PCSK9 Antibody Patents
Justices question what Amgen’s invention covers in its dispute with Sanofi. They appear inclined to uphold Federal Circuit’s standard for enablement despite potential negative impact on genus claims.