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Top related persons:
Lou Gehrig’s - 1 drugmaker - 1 they’re - 1 ” - 1 Marc Scheineson - 1 Brian Wallach - 1 Wallach - 1 “ - 1
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White Oak , Maryland U.S Bengaluru
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FDA - 2 ALS Association - 2 WASHINGTON - 1 Drug Administration - 1 drugmakers - 1 Congress - 1 Obama White House - 1 Mayo Clinic - 1

Search resuls for: "NurOwn"


2 mentions found


☆ FDA Skeptical of Experimental ALS Treatment Pushed by Patient Advocates
  + stars: | 2023-09-25 | by ( Associated Press | Sept. | At A.M. | ) www.usnews.com   time to read: +7 min
Those advocates still face one giant hurdle: FDA regulators say the treatment hasn't been shown to work. But with the backing of thousands of ALS patients, Brainstorm took the rare step of “filing over protest,” essentially forcing the agency to render a decision. Still, ALS patients see reasons for optimism. At Wednesday’s meeting, people with such reservations are certain to be outnumbered by appeals from ALS patients and their families. That compromise would be similar to FDA's approach to Relyvrio last year, another ALS drug with questionable data.
Persons: Lou Gehrig’s, drugmaker, they’re, ”, Marc Scheineson, Brian Wallach, Wallach, “, Brainstorm’s, NurOwn, Patricia Manhardt, Anthony Windebank, reanalyzing, weren’t, Terry Heiman, Patterson, it’s, Holly Fernandez Lynch, Matthew Perrone Organizations: WASHINGTON, Drug Administration, FDA, drugmakers, Congress, Obama White House, ALS Association, Mayo Clinic, Physicians, Temple University, University of Pennsylvania, Twitter, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP
☆ FDA staff reviewers raise concerns over BrainStorm Cell's ALS therapy
  + stars: | 2023-09-25 | by ( ) www.reuters.com   time to read: +2 min
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. Brainstrom's therapy, NurOwn, is being reviewed for the treatment of ALS, also known as Lou Gehrig's Disease, which affects nerve cells in the brain and spinal cord. The FDA had in November last year refused to accept the application for the therapy after BrainStorm failed to meet the main goal in a late-stage study. Over the last one year, the FDA has given accelerated approvals to Amylyx Pharmaceuticals' (AMLX.O) drug Relyvrio and Biogen's (BIIB.O) Qalsody for treatment of ALS. A panel of external advisors to the FDA is set to vote on the effectiveness of the therapy in ALS patients on Wednesday.
Persons: Andrew Kelly, Lou Gehrig's Disease, Amylyx, Mariam Sunny, Leroy Leo, Krishna Chandra Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug, Cell Therapeutics, Amylyx Pharmaceuticals, ALS Association, Thomson Locations: White Oak , Maryland, U.S, Bengaluru
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