Joseph Sullivan, MD: Efficacy of ZX008 in Dravet Syndrome
February 12th 2019The director of the Pediatric Epilepsy Center at UCSF Benioff Children’s Hospital discussed the efficacy profile of ZX008, for which Zogenix recently submitted a new drug application to the FDA for the treatment of Dravet syndrome.
FDA Issues Warnings About Dietary Supplements Claiming to Treat, Cure Alzheimer Disease
February 11th 2019A number of warning and online advisory letters were issued to 17 companies selling almost 60 products claiming to prevent, treat, or cure Alzheimer disease, among a number of health conditions.
Late-Window Thrombectomy Shows Benefit for Transferred Patients with Ischemic Stroke
February 10th 2019The investigators concluded that these findings have implications which suggest that transferring patients for late-window thrombectomy is associated with substantial clinical benefits and should be strongly encouraged.
ALS Diagnostic Index Dependably Distinguishes ALS From Mimicking Disorders
February 9th 2019The study provided Class I evidence that the ALSDI can help the confirmation and diagnosis of ALS and its mimicking conditions at the earliest stages of the disease, when therapeutic efforts are most efficacious.
The Pipeline for Primary Mitochondrial Myopathy Finds Promise with Elamipretide
February 8th 2019The professor of pediatrics at Northeast Ohio Medical University and the director of the NeuroDevelopmental Science Center at Akron Children’s Hospital provided insight into the therapeutic landscape of PMM.
Early Rehabilitation Associated with Improved Outcomes in Aneurysmal Subarachnoid Hemorrhage
February 7th 2019The stroke specialist at the Cerebrovascular Center at Cleveland Clinic detailed how patients who were rehabilitated earlier were shown to have better outcomes and a shorter stay in the intensive care unit in this study.
Zogenix Submits NDA for ZX008 for Dravet Syndrome
February 7th 2019The NDA for Zogenix's fenfluramine therapy is supported by data from 2 phase 3 trials in Dravet syndrome, as well as an interim analysis from the company’s ongoing open-label extension study, which includes 232 patients treated for up to 21 months.
Locum Tenens Combats Burnout: One Neurologist’s View
February 6th 2019It is not clear why neurologists have attained the dubious honor of being tied for first place for burnout, but excessive clerical work, long hours, nights on call, and the pressure to see high numbers of complex patients probably contribute.
Lemborexant Shows Positives for Treating Insomnia at Six Months
February 5th 2019At the end of the 6-month, placebo-controlled treatment period, treatment with lemborexant at 5 mg or 10 mg resulted in statistically significant improvements compared to placebo in patient-reported sleep onset latency, subjective sleep efficiency, and subjective wake after sleep onset.
BHV-3500 Meets Target Exposures for Migraine, Will Continue to Phase 2 Trial
February 5th 2019The phase 2 trial for the CGRP receptor agonist is planned for Q2 of 2019 after the intranasal treatment met its target therapeutic exposures in phase 1. Biohaven submitted an IND to the FDA in September 2018.
Temelimab Shows Promise in Multiple Sclerosis In Phase 1 Trial
February 5th 2019The phase 1 trial assessed high doses of the therapy in 24 healthy volunteers, divvied up into 4 cohorts to receive doses, including 36 mg/kg, 60 mg/kg, 85 mg/kg, and 110 mg/kg. These data build upon the findings of the phase 2b CHANGE-MS trial.
Dr. Reddy's Laboratories Continues Voluntary Recall of Levetiracetam Injection
February 4th 2019The recall began in October 2018, was initiated due to a mislabeling on the pre-printed content on the infusion bag for lot ABD807. Thus far, there have been no reported adverse events related to this recall.