Surrogate markers are seductive. In clinical trials and regulatory decisions, why not reach for something quick, convenient, and relatively cheap? Why stop patients receiving a treatment of plausible and potential benefit? That is the logic behind “accelerated pathways” for drug approval, such as the one used by the US Food and Drug Administration since the 1990s. But the FDA’s experience is…
Amyotrophic Lateral Sclerosis (ALS) is a multifactorial neurodegenerative disorder with a significant contribution of non-cell autonomous mechanisms to motor neuronal degeneration. Amongst a plethora of…
Topline data show where sodium phenylbutyrate and taurursodiol fell short
Bob Dagher, MD, Promoted to Chief Medical Officer Dr. Stacy Lindborg Stepping Down as Co-CEO and Transitioning to Board of Directors NEW YORK, April 16,…
By Ben Glickman BrainStorm Cell Therapeutics named a new medical chief and said Co-Chief Executive Stacy Lindborg would step down ahead of a long-awaited…
Private investments in public equities, or PIPEs, are all the rage in biotech, but some investors resent the sharing of nonpublic information.
“Every 90 Minutes” has been a tagline that organizations have used for over a decade to describe how often someone dies from ALS in the…
CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory…
MENLO PARK, Calif., April 15, 2024 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the…
Companies are increasingly using fast-track approval processes to get unproven treatments to patients.
Experts are hopeful that objective biomarker measures for amyotrophic lateral sclerosis, such as the ones being developed by EverythingALS, will lead to more targeted, effective…
