DermWire | Newest Articles Newest Articles en-us Sat, 17 Feb 2018 23:56:17 GMT Sat, 17 Feb 2018 23:56:17 GMT DermWire Stryker's Trevo Retriever Now Indicated for Treating Stroke Up to 24 Hours From Symptom Onset Stryker has announced that its Trevo Retriever device has received an expanded indication from the US Food and Drug Administration (FDA) as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from onset. According to Stryker, the Trevo Retriever is the first thrombectomy device to receive FDA approval to reduce disability in patients up to 24 hours after onset of symptoms, which increases the treatment window by 18 hours. Until this expanded indication, mecha… Thu, 15 Feb 2018 04:00:00 GMT Food and Drug Administration Permits Marketing of First Blood Test to Evaluate Concussion As part of the breakthrough devices program, the Food and Drug Administration (FDA) permitted marketing of the brain trauma indicator (Banyan Biomarkers, Inc; San Diego, California), the first blood test for a biomarker of mild traumatic brain injury (mTBI), or concussion, in adult patients. The breakthrough devices program paved the way for review and approval by the FDA in fewer than 6 months. This is a regulatory pathway for some low- to moderate-risk devices that are novel and for which ther… Wed, 14 Feb 2018 04:00:00 GMT New Dose of Generic Glatiramer Acetate Injection for Treatment of Relapsing Multiple Sclerosis Approved by Food and Drug Administration Sandoz announced that the Food and Drug Administraion (FDA) had approved a generic form of glatiramer acetate (Glatopa,Sandoz) in injectable form at a dose of 40 mg/mL 3 times per week for relapsing forms of multiple sclerosis (MS). The launch of this dose of glatiramer acetate by Sandoz provides patients a complete range of dosing options with a generic form of the drug. A 20 mg/mL dose was previously launched by Sandoz in June 2015. Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-app… Wed, 14 Feb 2018 04:00:00 GMT Pediatricians, Pediatric Neurologists, Patient Advocates, and Industry Partner to Create High-Tech Risk-Screening Tool for Children with Epilepsy Digital Health Solutions (DHS), the Child Neurology Foundation (CNF), and Greenwich Biosciences began a collaborative effort to develop a digital tool that will prompt providers to communicate with caregivers of children living with epilepsy about the risk of sudden unexpected death in epilepsy (SUDEP) and associated risk factors. The Centers for Disease Control and Prevention reports that there are 470,000 children living with epilepsy in the US. In April 2017, the American Academy of Neurology… Tue, 13 Feb 2018 04:00:00 GMT Alkahest Receives Grant From the The Michael J. Fox Foundation for Parkinson's Research for Clinical Trial of GRF6019 On February 12, 2018, Alkahest, a privately-held clinical-stage company developing treatments for age-related diseases announced that they had received funding from the Michal J. Fox Foundation for Parkinson’s Reseasrch (MJFF). Alkahest has an emphasis on neurodegeneration and cognitive dysfunction, which they consider current key medical challenges. The Alkahest pipeline includes novel products based on factors present in healthy plasma. Preclinical studies have shown that the plasma-d… Mon, 12 Feb 2018 04:00:00 GMT National Institutes of Health Researchers Adapt Test for Early Diagnosis of Parkinson's Disease and Dementia with Lewy Bodies Acta Neuropathologica Communications published a paper by researchers at the National Institutes of Health (NIH) (Groveman BR, Orrù CD, and Hughson AG, et al. Acta Neuropathol Comm. 2018;6:published online Feb 9) showing that an assay, α-synuclein real time quaking-induced conversion (αSyn RT-QuIC), for the pathogenic disease-associated forms of a-synuclein is sensitive, specific and practical for assessing the presence of those proteins in cerebrospinal fluid. Those specific … Fri, 9 Feb 2018 04:00:00 GMT Two Surveys for Diagnosing Mild Cognitive Impairment in Parkinson's Disease Approximately one-third of patients with Parkinson’s disease (PD) have dementia, leading to severe quality-of-life impairments in addition to those that are caused by the motor symptoms of PD. It has been previously been shown that patients with mild cognitive impairment (MCI) early in the course of PD are at increased risk of developing dementia. However, early diagnosis of MCI has been challenging until now. The Movement Disorders Journal has published an article by Emmie W. Koevets,… Thu, 8 Feb 2018 04:00:00 GMT Results from Phase 2 Trial of Stem-Cell Treatment for Amyotrophic Lateral Sclerosis to Be Presented at American Academy of Neurology 2018 Brainstorm Cell Therapeutics Inc. announced that they will present results from the NurOwn phase 2 randomized, double-blind, placebo-controlled study, showing ALSFRS-R subgroup analyses and micro-RNA biomarker data, at the American Academy of Neurology (AAN) Annual Meeting, to take place April 21-27th in Los Angeles, California. The data will be presented in platform sessions including: "NurOwn® Phase 2 ALS Trial: ALSFRS-R Improvement is Reflected in Subscale Domains" Sess… Wed, 7 Feb 2018 04:00:00 GMT 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’s disease (PD) alone or, more commonly, as an adjunct to treatment with levodopa. Pramipexole is a dopamine agonist often used in early-stage PD treatment with the goal of postponing initiation of levodopa treatment due to the significant complications of prolonged use of levodopa. Based on posit… Wed, 7 Feb 2018 04:00:00 GMT Food and Drug Administration Grants Breakthrough Therapy Designation for ZX008 for Treatment of Dravet Syndrome Low-dose fenfluramine (ZX008, Zogenix) is classified as an orphan drug for the treatment of two rare forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome. Positive results from the first pivotal phase 3 trial of ZX008 by Zogenix for treatment of Dravet syndrome have led to it being first, fast-tracked, and now, granted breakthrough therapy status by the Food and Drug Administration (FDA). Dravet syndrome is a rare (incidence 1:20,900), polymorphic epilepsy of infancy, also known as … Tue, 6 Feb 2018 04:00:00 GMT Caregiving for Dementia Innovation Challenge Award Winners Announced AARP Services Inc and United Healthcare announced 2 winners in their Caregiving for Dementia Innovation Challenge out of 254 entries from 34 countries. The goal of the challenge was to identify and create new solutions to support family caregivers for patients with early to midstage dementia. Globally there are more than 50 million patients with dementia, affecting approximately 25% of all family caregivers, with significant emotional and physical stressors. Entries in the challenge shared re… Mon, 5 Feb 2018 04:00:00 GMT Frozen Gait in Parkinson's Disease Is Influenced by Emotional Stimuli In a study published in Movement Disorders, Lagravinese and colleagues have shown that gait initiation in patients with Parkinson’s disease (PD) is affected by the presence of an emotional stimuli (Movement Disorders. 2018;33:published online February 2, 2018). Subjects with PD and frozen gait (n = 15), subjects with PD and without frozen gait (n = 15), and subjects with neither (normal controls, n = 14) were asked to step both forward and backward upon seeing a pleasant or unpleasant imag… Mon, 5 Feb 2018 04:00:00 GMT Post Hoc Clinical Trials Data for Cladribine, An Investigational Oral Multiple Sclerosis Treatment EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, announced that new clinical trial data is being released during the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) meeting February 1-3, 2018. The results evaluate safety of cladribine tablets and the effect of cladribine on the immune system via post hoc analyses of 3 clinical trials, a phase 2 clinical trial, and a registry study. In the U. S., cladribine is currently under clinical … Thu, 1 Feb 2018 04:00:00 GMT Innovative Drug Combination Addresses Neuroinflammatory Response and Amyloid-Beta Accumulation Associated with Alzheimer's Disease AZTherapies, Inc., an advanced clinical stage pharmaceutical company developing breakthrough treatments for neurologic diseases associated with neuroinflammation and neurodegeneration, announced publication of results in Nature’s Scientific Reports supporting use of ALZT-OP1 as a therapeutic agent for Alzheimer’s disease (AD) (Zhang C, Griuc A, Hudry E, et al. Sci Rep. 2018;8:published online January 18, 2018). ALXT-OP1 is a combination therapy that uses two re-engineered drugs, c… Wed, 31 Jan 2018 04:00:00 GMT The National Institutes of Health Launches "Accelerating Medicines Partnership Parkinson's Disease" to Advance Treatment Research As part of their Accelerating Medicines Partnership (AMP) initiative, which aims to foster collaboration among government, biopharmaceutical, life science, and non-profit organizations to advance medical treatment, the National Institutes of Health (NIH) launched AMP Parkinson’s disease (AMP PD). The goal of the project is to overcome obstacles and increase successful treatment advances for Parkinson’s disease (PD). AMP PD will focus on biomarkers for tracking the progression of PD … Tue, 30 Jan 2018 04:00:00 GMT First Prospective Registry Shows Efficacy of Neuromodulation of the Sphenopalatine Ganglion for Treating Cluster Headache On January 25, 2018, The Journal of Headache and Pain published one-year results from an open-label registry trial, Pathway R-1, evaluating the efficacy of sphenopalatine-ganglion stimulation (SPGs) (Pulsante, Autonomic Technologies) for the treatment of both chronic and episodic cluster headache. Over a full 12 months, 85 patients with cluster headache (78 chronic and 7 episodic) were followed, and 68% of patients had a significant reduction in the frequency of cluster-headache attacks and/… Thu, 25 Jan 2018 04:00:00 GMT New Treatment Guidelines for Acute Ischemic Stroke Open the “Golden Window” for Treatment to 6-24 Hours The American Heart Association (AHA) and the American Stroke Association announced new evidence-based guidelines (Stroke. 2018;49:published online January 24, 2018.) for treatment of adults with acute ischemic stroke (AIS) replacing previous guidelines published in 2013 (Stroke. 2013;44:870 -- 947). The new guidelines are endorsed by the American Association of Neurologic Surgeons, the Congress of Neurologic Surgeons, and the Society of Academic Emergency Physicians. Prehospital-, urgent-, a… Wed, 24 Jan 2018 04:00:00 GMT Applications Being Accepted for the Science and PINS $25, 000 Prize for Neuromodulation The American Association for the Advancement of Science (AAAS), publisher of the journal Science announced on January 23, 2018, that they are accepting applications for the Science and PINS Prize for Neuromodulation. This is a highly competitive prize that honors scientists making contributions to research in neuromodulation, defined as “any alteration of nerve activity through delivery of physical (electrical, magnetic, optical) stimulation to targeted sites of the nervous system.” … Tue, 23 Jan 2018 04:00:00 GMT The Generational Technology Gap May Be Closing—Even in Patients with Dementia Senior Helpers, a provider of in-home services for seniors who wish to remain in their homes despite age-related illnesses and mobility challenges including dementia, Alzheimer’s disease, and Parkinson’s disease, shared results of a survey of 1,000 of their clients regarding their attitudes to and use of technology. They found that more than 68% of respondents, who were 65 years of age and older, rated their technology skills average or above average. The survey examined seniors&… Tue, 16 Jan 2018 04:00:00 GMT 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 vein thrombosis (DVT) and pulmonary embolism (PE) or to help prevent stroke and blood clots in patients with atrial fibrillation without heart valve disease. Rivaroxaban may reduce the risk of DVT, which can lead to PE in people who are having hip replacement or knee replacement surgery. The Food… Tue, 16 Jan 2018 04:00:00 GMT Parkinson’s Outcomes Project Enrolls 10,000th Patient and Releases Key Findings The "Parkinson's Outcomes Project," launched in 2009 as a small pilot and funded by the Parkinson's Foundation, met a major milestone goal with the enrollment of its 10,000th patient. This clinical study, the largest of Parkinson’s disease (PD) to date, has grown to international scope and includes 29 expert clinics and investigators in the United States, the Netherlands, Canada, and Israel. Over 25,000 clinical visits and information from almost 9,000 family care partne… Wed, 10 Jan 2018 04:00:00 GMT Sublingual Formulation of Riluzole Bioequivalent to Tablet Formulation Biohaven announced positive results from its bioequivalence study of BHV-0223, an innovative sublingual formulation of riluzole, currently available as a 50-mg tablet, which is currently the standard-of-care treatment for patients with Amyotrophic Lateral Sclerosis (ALS), but can be difficult for patients with ALS to swallow. Topline results in a study with 138 healthy volunteers who were administered 40 mg of BHV-0223 sublingually and 50 mg of riluzole in tablet form under fasted conditions sho… Tue, 9 Jan 2018 04:00:00 GMT Guidance for the Use of Opioids in the Treatment of Refractory Restless Leg Syndrome On January 8, 2018, Mayo Clinic Proceedings published an article on appropriate use of opioids for treating refractory restless legs syndrome (RLS) by members of the Scientific and Medical Advisory Board of the Restless Legs Syndrome Foundation (Mayo Clin Proc. 2018;93:59-67.) The article offers guidance for clinicians on the appropriate use of opioids to treat refractory RLS, including monitoring, addiction risk assessment, and safe prescribing practices. The incidence of RLS is estimated a… Mon, 8 Jan 2018 04:00:00 GMT FDA Grants Approval for Senza II Spinal Cord Stimulation System Delivering HF10 Therapy On January 8th, 2018, Nevro Corporation, a global medical device company, announced that it has received approval from the Food and Drug Administration (FDA) for its next-generation Senza II Spinal Cord Stimulation (SCS) System delivering high-frequency (HF10) spinal cord stimulation (SCS) at 10,000 Hz. Traditional SCS delivers electrical pulses at less than 1,200 Hz and usually between 40-60 Hz, creating paresthesia that is thought to “mask” the patient’s sensation of pain. In… Mon, 8 Jan 2018 04:00:00 GMT 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% or more in 3 of 5 patients treated, and that 33% had ≥ 75% reduction in headache days per month with a 52% reduction in migraine risk beginning on day 1. Eptinezumab is a monoclonal antibody that targets CGRP. Alder plans to file a biologics license application in the second half of 2018. If appro… Mon, 8 Jan 2018 04:00:00 GMT