Latest News - Neuromuscular & Immune Disorders

Tuesday, May 23, 2017 | Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications

Celgene’s Investigational MS Agent Reduces Annual Relapse Rate but Falls Short of Disability Endpoint in Phase 3 Trial

New Phase 3 findings suggest that Celgene’s investigational ozanimod for relapsing multiple sclerosis (MS) reduces annualized relapse rate in a clinically meaningful way but does not significant…

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Friday, May 05, 2017 | FDA Approval/Clearance, Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications

FDA Greenlights First New Treatment for ALS in More than Two Decades

The FDA has approved Radicava (edaravone, MT Pharma), as an intravenous infusion treatment for amyotrophic lateral sclerosis (ALS). Radicava is the first treatment approved for the treatment of A…

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Thursday, May 04, 2017 | Neuromuscular & Immune Disorders, Product Launches and Updates, Research and Publications

MS Topography App Launches

A new app that offers a new, visual way of understanding multiple sclerosis (MS) was recently launched at the American Academy of Neurology Annual Meeting in Boston. The app is a disease simulation th…

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Wednesday, April 26, 2017 | Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications, Genentech

AAN 2017 Meeting: New Data Reinforce Efficacy of Ocrelizumab

New data presented at the American Academy of Neurology (AAN) Annual Meeting in Boston show the benefits of ocrelizumab in relapsing multiple sclerosis (MS). In a pooled analysis of Phase 3 …

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Tuesday, April 04, 2017 | FDA Approval/Clearance, Movement Disorders, Neuromuscular & Immune Disorders, Phase 3/4 Trials

New Therapy for Chorea Associated with Huntington’s Disease Wins FDA Approval

The FDA approved Austedo (deutetrabenazine, Teva Pharmaceuticals) tablets for the treatment of chorea associated with Huntington’s disease (HD), making it just the second product approved for th…

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Tuesday, March 28, 2017 | Clinical Trials, FDA Approval/Clearance, Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications, Genentech, Roche

Ocrevus Receives FDA Greenlight for Relapsing, Primary Progressive Forms of Multiple Sclerosis

The FDA has approved Ocrevus (ocrelizumab, Roche/Genentech) for the treatment of both relapsing and primary progressive forms of multiple sclerosis. Ocrelizumab is a humanized antibody that …

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Friday, February 17, 2017 | Neuromuscular & Immune Disorders

FDA Accepts NDA Filing for MT Pharma’s Investigational ALS Treatment

The FDA accepted the Mitsubishi Tanabe Pharma’s New Drug Application (NDA) for edaravone (MCI-186), an intravenous treatment for amyotrophic lateral sclerosis (ALS). Edaravone is described as a …

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Friday, February 10, 2017 | FDA Approval/Clearance, Neuromuscular & Immune Disorders

New Corticosteroid Approved for Duchenne Muscular Dystrophy

The FDA approved Emflaza (deflazacort) tablets and oral suspension to treat patients age five years and older with Duchenne muscular dystrophy (DMD). Emflaza is the first FDA approved corticosteroid t…

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Tuesday, February 07, 2017 | Neuromuscular & Immune Disorders, Research and Publications

Blood Biomarker for Quick and Accurate Prognosis of MS Identified

A newly discovered blood biomarker may aid physicians in identifying the type of multiple sclerosis (MS) in their patients. In a study recently published in Scientific Reports, investigators evaluated…

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Wednesday, January 04, 2017 | Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications, Genentech

Newly Published Phase 3 Data Boost Efficacy Profile of Ocrevus in Primary Progressive and Relapsing MS

As the FDA continues its review of the Biologics License Application (BLA) for Genentech’s Ocrevus (ocrelizumab), key phase 3 findings reviewing the agent’s safety and efficacy in relapsin…

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Wednesday, December 21, 2016 | FDA Approval/Clearance, Neuromuscular & Immune Disorders, Genentech, Roche

FDA Extends Review of MS Agent Ocrevus to March 2017

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application of Genentech’s investigational agent for the treatment of multiple sclero…

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Thursday, October 27, 2016 | Neuromuscular & Immune Disorders

The Assistance Fund Now Providing Financial Assistance to Patients with Duchenne Muscular Dystrophy

The Assistance Fund, an independent charitable foundation, is opening a new fund to providing financial assistance for patients living with Duchenne muscular dystrophy. The Duchenne Muscular Dystrophy…

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