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Monday, March 25, 2019

First Participant Treated with Proprietary Plasma Fraction in Phase 2 Trial for Severe Alzheimer’s Disease

In a phase 2 clinical trial (NCT03765762), the first participant has received a dose of the proprietary plasma fraction (PPF)(GRF6019) developed by Alkahest (San Carlos, CA) in partnership with Grifol…

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Monday, March 25, 2019

Gene Delivery Into Ependymal Cells Lining Ventricles for Batten’s Disease

As genetic therapy for neurologic diseases moves toward the mainstream, a key challenge that must be addressed is the need to deliver genes to the central nervous system (CNS) and ensure that the func…

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Thursday, March 21, 2019

Patient Advocacy Organizations Join Forces to Improve Care for Spinal Muscular Atrophy

Patient advocacy organizations are partnering to obtain real-world evidence to advance research, drug development, and access to therapies for children and adults with spinal muscular atrophy (SMA).&n…

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Thursday, March 21, 2019

FDA Approves Solriamfetol for Treatment of Excessive Daytime Sleepiness

The Food and Drug Administration (FDA) has approved solriamfetol (Sunosi; Jazz Pharmaceuticals, Dublin, Ireland) for the treatment of adults with excessive daytime sleepiness (EDS)associated with narc…

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Monday, March 18, 2019

“Recovery Sleep” on Weekend Does Not Make Up for Lost Sleep During the Week

  Research published in Current Biologyshows that sleeping on the weekends to make up for lost sleep during the week has no beneficial effect for adults. In this small study, 36 healthy m…

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Friday, March 15, 2019

Patient’s Risk Tolerance for Disease Modifying Treatments for Multiple Sclerosis

In a study published in Neurology, researchers at the Cleveland Clinic evaluated patients’ tolerance for potential risks of multiple sclerosis (MS) medications. Studies show that 40% or mor…

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Friday, March 15, 2019

First Patient Enrolled in Phase 3 Study of Troriluzole for Spinocerebellar Ataxia

The first patient has been enrolled in a phase 3 study (NCT03701399) of troriluzole (Biohaven, New Haven, CT) to treat spinocerebellar ataxia (SCA). The primary outcome measure of the trial is improve…

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Wednesday, March 13, 2019

Rivaroxaban, Dabigatran Reduce Ischemic Stroke and Intracranial Hemorrhage in Those With Nonvalvular Atrial Fibrillation

A large meta-analysis of 95 studies published in the Journal of Market Access and Health Policy, showed that treatment with rivaroxaban (Xarelto; Janssen Pharmaceuticals, Titusville, NJ) signific…

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Tuesday, March 12, 2019

Small Study Shows Similar Outcomes for “Drip & Stay” Vs “Drip & Ship” for Ischemic Stroke

In a study published in Stroke, there were no significant differences in the number of patients achieving a good outcome (90-day modified Rankin score [mRS] < 2) when comparing patients treate…

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Tuesday, March 12, 2019

New Drug Application Accepted for Lemborexant for Treatment of Insomnia

The Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for lemborexant (Eisai, Woodcliff Lake, NJ). Lemborexant is novel small molecule being investigated for treatment of insomn…

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Monday, March 11, 2019

First Cohort Fully Treated in Phase 1/2a Study of Cell Transplants for Treatment of Amyotrophic Lateral Sclerosis

In a phase 1/2a study, 5 patients with amyotrophic lateral scleroris (ALS) have had healthy astrocytes derived from stem cells (AstroRx; Kadimastem, Ness Ziona, Israel) transplanted intrathecally. The…

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Monday, March 11, 2019

New Drug Application Accepted for Ubrogepant for Acute Migraine Treatment

The Food and Drug Administration (FDA) has accepted the new drug application (NDA) for ubrogepant for acute migraine treatment (Allergan, Madison, NJ) and set a 10-month review period. If approve…

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Friday, March 08, 2019

Phase 3 Open Label Extension Study for BAN 2401 for Mild Cognitive Impairment Launches

A phase 3 study to investigate a humanized monoclonal antibody as a potential therapy for mild cognitive impairment from Alzheimer’s disease (AD)began this month. The open-label extension s…

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Thursday, March 07, 2019

Analysis of Cladribine Tablets Clinical Trials Continues to Support Safety and Efficacy

In the 2-year CLARITY trial (NCT00213135), 47% of patients treated with cladribine tablets (CT) (EMD Serono; Rockland, MA) achieved no evidence of disease activity (NEDA) compared with 17% of patients…

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Wednesday, March 06, 2019

FDA Grants Priority Review to Galcanezumab for Prevention of Cluster Headache

The Food and Drug Administration (FDA) has granted priority review status to the supplemental biologics license application (sBLA) for galcanezumab-gnlm (Emgality; Eli Lilly and Company, Indianapolis,…

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