Latest News - Phase 3/4 Trials

Wednesday, August 01, 2018

First Patient Enrolled in Phase 3 Study of Athersys’ Stem Cell Treatment for Patients who Experienced Ischemic Stroke

The first patient has been enrolled in a phase 3 study, MASTERS-2 (NCT03545607), which is a pivotal study that has received special protocol assessment, fast-track designation, and regenerative medici…

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Wednesday, February 07, 2018

Phase 3 Trial of P2B001 for Early-Stage Parkinson's Disease Begins With First Patients Receiving First Dose

The drug P2B001(Pharma Two B) is a combination product of pramipexole 0.6mg and rasagiline 0.75 mg given together once daily. Rasagiline is a monoamine oxidase inhibitor used to treat Parkinson&r…

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Tuesday, January 16, 2018

The Food and Drug Administration Mini-Sentinal Shows Rivaroxaban Is Associated with a Lower Risk of Ischemic Stroke Vs. Warfarin

Rivaroxaban (Janssen Pharmaceuticals) is an antithrombotic medication that inhibits clotting Factor Xa. It is available in oral tablet formulation for patients at risk of, or being treated for, deep v…

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Monday, January 08, 2018

PROMISE Phase 3 Trial for Chronic Migraine Prevention Meets Primary and All Key Secondary Endpoints; Shows Reduction in Migraine Risk

January 8, 2018--Alder Biopharmaceutical reported that their injectable calcitonin-gene-related peptide (CGRP)-inhibitor eptinezumab, in phase 3 clinical trials, reduced monthly migraine days by 50% o…

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Friday, October 27, 2017

ECTRIMS: First-in-Class Monoclonal Antibody Shows Promise in Phase 2 Data

Results from the Phase 2 SYNERGY trial suggest that the investigational opicinumab (Biogen) could have an increased clinical effect in patients with relapsing multiple sclerosis (MS) who had the disea…

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Tuesday, October 24, 2017

FDA Fast-Tracks Alzheon’s Anti-Amyloid Alzheimer’s Agent

The FDA has granted Fast Track designation to Alzheon, Inc.’s investigational anti-amyloid drug ALZ-801 for the treatment of Alzheimer’s disease (AD). Using a precision medicine approach, …

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Friday, September 29, 2017

Investigational Low-Dose Fenfluramine Shows Promise in Phase 3 Trial for Dravet Syndrome

Phase 3 findings suggest that the investigational ZX008 (low-dose fenfluramine hydrochloride, Zogenix) is effective for the treatment of Dravet syndrome. The study enrolled 119 patients across sites i…

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Tuesday, September 05, 2017

CLARITY Extension: Annual Short-Course Therapy with Investigational Oral Agent Effective in Relapsing MS

New results suggest that patients with relapsing multiple sclerosis (MS) treated with two annual short courses of the investigational cladribine tablets (EMD Serono) may have similar clinical benefits…

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Tuesday, June 27, 2017

Low-Dose Fenfluramine Granted Orphan Status for LGS

The FDA has granted orphan drug designation to ZX008 (Zogenix), an investigational treatment for Lennox Gastaut Syndrome (LGS). Zogenix will initiate a Phase 3 clinical trial in LGS in second half of …

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Wednesday, June 14, 2017

Phase 3 Results Published for Investigational Levodopa-Induced Dyskinesia Treatment

Results from the Phase 3 EASE LID clinical trial, published online in JAMA Neurology, show that the investigational ADS-5102 (amantadine, Adamas Pharmaceuticals) reduces levodopa-induced dyskinesia (L…

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Tuesday, June 13, 2017

AHS 2017: Amgen’s CGRP Inhibitor Reduces Migraine Days

New Phase 2 data show that Amgen’s investigational investigational CGRP inhibitor erenumab is effective at preventing migraine in patients experiencing 15 or more migraine days per month. In a s…

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Thursday, June 08, 2017

AHS 2017 Meeting: Prochlorperazine More Effective than Hydromorphone for Acute Migraine

A new comparative study presented at the American Headache Society Annual Meeting in Boston shows that that, in patients who visit the emergency department for acute migraine treatment, prochorperazin…

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Friday, May 12, 2017

Lilly’s Investigational Monoclonal Antibody for Migraine Scores Positive Phase 3 Results

New Phase 3 data suggest that Eli Lilly’s investigational monoclonal antibody galcanezumab may significantly reduce the number of monthly migraine headache days. In the EVOLVE-1 study, pati…

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Tuesday, April 04, 2017

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

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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