Latest News - Phase 3/4 Trials

Tuesday, November 07, 2017

Oral Vimpat Approved for Use in Pediatric Patients with Partial-Onset Seizures

The FDA approved a label extension for Vimpat (lacosamide, UCB) CV as an oral option for the treatment of partial-onset seizures (POS) in pediatric patients four years and older. The expanded ind…

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Friday, October 27, 2017

ECTRIMS: EMD Serono Highlights Risk-Benefit Profile of Cladribine Tablets for Relapsing MS

Data from a post-hoc analysis presented by Merck at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris show that investigational Cladribine Tablets significantly increases the proportion of patients with …

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Friday, October 27, 2017

ECTRIMS: Alkermes Demontrates Safety and GI Tolerability of Investigational Oral Agent for Relapsing MS

Alkermes presented safety and gastrointestinal (GI) tolerability data from EVOLVE-MS-1, an ongoing open-label, two-year phase 3 safety study for ALKS 8700, a novel, oral monomethyl fumarate (MMF) prod…

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Friday, October 27, 2017

ECTRIMS: Genentech Data Signals Emphasis on Multiple Sclerosis Disease Progression, Disability

Data presented by Genentech at the 7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) -- Americas Committee for Treatment and Research in Multiple Sclerosis (ACT…

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Thursday, October 12, 2017

Once-Daily Lyrica Formulation Wins FDA Approval

The FDA has approved Lyrica CR (pregabalin, Pfizer) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and t…

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Thursday, June 08, 2017

AHS 2017 Meeting: Non-Invasive Medical Devices Show Promise for Severe Headaches

Results from studies presented at the American Headache Society Annual Meeting in Boston suggest that non-invasive medical devices offer effective interventions for individuals with migraine. …

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Thursday, June 01, 2017

Teva’s Fremanezumab Reduces Monthly Headache Days in Phase 3 Chronic Migraine Study

    Results from the Phase 3 HALO study suggest that fremanezumab (Teva Pharmaceuticals) reduces the number of monthly headache days in patients with chronic migraine. Fremanezumab is …

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Friday, May 26, 2017

NEJM Publishes Phase 3 Data for Epidiolex in Dravet Syndrome as Manufacturer Eyes Mid-2017 NDA Submission

The New England Journal of Medicine has published results from a Phase 3 study showing that Epidiolex (cannabidiol, GW Pharmaceuticals) reduces monthly convulsive seizure frequency compared to placebo…

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Tuesday, May 23, 2017

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 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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Wednesday, May 03, 2017

New Data Highlight Efficacy and Safety of Brain Responsive Neuromodulation for Reduction of Seizures

Two new studies offer long-term perspective on the efficacy and safety of brain responsive neuromodulation for the reduction of seizures. One study evaluated the effects of NeuroPace’s RNS Syste…

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Wednesday, April 26, 2017

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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Thursday, January 05, 2017

Neuronix Reveals Data Suggesting Non-invasive TMS Device Improves Cognitive Performance in Alzheimer’s Disease

New findings suggest that an investigational device that combines transcranial magnetic stimulation (TMS) with cognitive training may improve cognitive performance in individuals with Alzheimer&r…

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Thursday, November 17, 2016

Investigational Biologic for the Treatment of Migraine Shows Promise in Phase 3 Data

New Phase 3 trial results suggest that Amgen’s investigational biologic agent erenumab may be effective at reducing migraines. Erenumab was specifically designed to prevent migraine by bloc…

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