Under a new directive from the Centers for Medicare and Medicaid Services (CMS), Medicare Advantage plans are now required to cover QALSODY® (tofersen), Biogen’s recently-approved treatment for people living with SOD1-ALS. We strongly support this new directive. Study results suggest …
Les Turner ALS Center at Northwestern Medicine and Sean M. Healey & AMG Center for ALS Establish Acceleration Centers of Enrollment Initiative
Together with the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, the Les Turner ALS Center at Northwestern Medicine is thrilled to announce the launch of the Acceleration Centers of Enrollment (ACE) initiative. The ACE initiative …
Making Clinical Research Accessible: Insights from a Research Professional
Clinical research at the Lois Insolia Clinic at the Les Turner ALS Center at Northwestern Medicine plays a pivotal role in helping researchers understand the causes of ALS and how to develop better treatments for the disease. But many people …
Lois Insolia ALS Clinic Opens Enrollment for New HEALEY ALS Platform Trial Regimen
The Lois Insolia ALS Clinic at the Les Turner ALS Center at Northwestern Medicine is now an active site for Regimen F of the HEALEY ALS Platform Trial. The focus of Regimen F is ABBV-CLS-7262, an investigational product being developed …
FDA Approves tofersen (Qalsody™) for Treatment of SOD1-ALS
We are pleased that the FDA has granted accelerated approval to tofersen for treatment of SOD1-ALS. As the first FDA-approved treatment to target a genetic cause of ALS, this is a landmark moment for the ALS community. We are grateful …
FDA Advisory Committee Recommends Accelerated Approval of tofersen
Watch our oral testimony at the FDA Advisory Committee meeting on March 22, 2023. We are grateful to the FDA Advisory Committee for reviewing the evidence, listening to the ALS community and voting to recommend accelerated approval of tofersen for …
Oral Testimony to the FDA Advisory Committee on the Approval of tofersen
Delivered by Lauren Webb, LCSW, Chief Advocacy and Outreach Officer of the Les Turner ALS Foundation. See also remarks by Senda Ajroud-Driss, MD, Director of the Lois Insolia ALS Clinic at the Les Turner ALS Center at Northwestern Medicine. Open …
Comments to the FDA Advisory Committee in Support of Tofersen Approval
RE: FDA-2022-N-0691 Dear FDA Advisory Committee: We write to express our strong support for the approval of tofersen under the FDA’s Accelerated Approval Program. Our organization’s long history of scientific research into SOD1-ALS and our depth of experience supporting people …
Newly published data on tofersen shows success in treating SOD1-ALS
New results published this week provide further evidence that tofersen, a drug in development by Biogen, may be effective in slowing the progression of SOD1-ALS. As reported in the New England Journal of Medicine, the Phase 3 clinical trial (VALOR) …
FDA grants priority review for new SOD1-ALS treatment
The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application for tofersen, a drug in development by Biogen for treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) – and granted priority review for the application. …
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