DermWire | Newest Articles Newest Articles en-us Mon, 11 Dec 2017 12:10:50 GMT Mon, 11 Dec 2017 12:10:50 GMT DermWire 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 indication is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children, according to the company. Data suggest that adverse reactions to oral Vimpat in pediatric patients are similar to those seen in adul… Tue, 7 Nov 2017 04:00:00 GMT 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 disease for shorter periods of time. The data, presented at the 7th Joint Meeting of the ECTRIMS-ACTRIMS in Paris, also showed that opicinumab, a first-in-class monoclonal antibody directed against LINGO-1, may be beneficial in patients whose MRI results show certain brain features that suggest repair of… Fri, 27 Oct 2017 04:00:00 GMT 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 relapsing multiple sclerosis (MS) in high disease activity subgroups with no evidence of disease activity (NEDA) compared with placebo (43.7% vs. 8.7%). The company also shared late-breaking safety analyses including patients with up to eight-years follow-up from monotherapy oral (3.5 mg/kg) cohorts… Fri, 27 Oct 2017 04:00:00 GMT 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) prodrug candidate in development for the treatment of relapsing multiple sclerosis (MS) at Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) in Paris. The study inclu… Fri, 27 Oct 2017 04:00:00 GMT 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 (ACTRIMS) Meeting in Paris highlight clinical advances around underlying disease activity and disability progression in relapsing and progressive forms of multiple sclerosis (MS). In a post-hoc analysis of more than 1,600 patients from the OPERA I and OPERA II trials comparing ocrelizumab (Ocrevus) to i… Fri, 27 Oct 2017 04:00:00 GMT Neural Analytics Partners with Department of Defense to Develop Portable Device to Assess Combat-Related TBI The Department of Defense (DoD) has awarded Neural Analytics, Inc. a $10 million contract to develop and supply a portable, point-of-injury device for assessing combat-related traumatic brain injury (TBI). Neural Analytics will partner with the DoD to develop its Lucid System within the next 18 months to measure and monitor physiological parameters relevant to moderate-severe TBI and to operate in prolonged field care scenarios. The system is expected to operate as a single, portable unit with m… Tue, 24 Oct 2017 04:00:00 GMT 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, Alzheon is evaluating ALZ-801 based on genetic markers and stage of the disease. ALZ-801 is an oral agent that has a novel molecular mechanism of action blocking the formation of toxic amyloid oligomers1 associated with the development and progression of AD. Clinical data for ALZ-801 and its active … Tue, 24 Oct 2017 04:00:00 GMT Corrona Partners with National MS Society on Registry to Assess Safety and Efficacy of Therapies Corrona, LLC and the National Multiple Sclerosis Society will collaborate on the launch of the Corrona Multiple Sclerosis (MS) Registry to study the comparative safety and effectiveness of approved MS therapies. The observational registry will collect and analyze longitudinal outcomes associated with multiple sclerosis therapies via questionnaires, physician assessments, and patient-reported outcomes. The first patient has been enrolled, with initial recruitment goals to register approximately 5… Fri, 20 Oct 2017 04:00:00 GMT Phenogenetic Database For Stem Cell Models of Neurological Diseases Launched Based on the results of a novel meta-analysis of all induced pluripotent stem cells, researchers have created an atlas of how cell characteristic in neurological and neurodegenerative diseases are linked to their genotype. In a study published online in the journal EMBO Molecular Medicine (E-pub October 19), investigators collected data from 93 studies on phenotypes and genotypes, encompassing 31 neurological diseases that span the pediatric to adult population with a total of 71 gene mutations.… Thu, 19 Oct 2017 04:00:00 GMT National Grant Awarded to Mount Sinai to Continue the New York Traumatic Brain Injury Model System The National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) has awarded the Icahn School of Medicine at Mount Sinai’s Department of Rehabilitation Medicine and the Brain Injury Research Center a five-year grant totaling $2.2 million to fund the New York Traumatic Brain Injury Model System at Mount Sinai to study traumatic brain injury (TBI). The grant will fund the work of researchers who will contribute to the largest study of TBI outcomes in the world, … Wed, 18 Oct 2017 04:00:00 GMT 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 the management of postherpetic neuralgia (PHN). The efficacy and safety of the new formulation was established in a randomized placebo-controlled clinical trial conducted in which 801 patients with PHN entered a six-week single-blind treatment with Lyrica CR followed by a 13-week double-blind phase. … Thu, 12 Oct 2017 04:00:00 GMT Next-Generation VNS System and Implantable Device Approved LivaNova has received FDA approval for its next-generation Vagus Nerve Stimulation (VNS) Therapy Programming System for drug-resistant epilepsy. The FDA has also approved the company's SenTiva implantable device, the smallest and lightest responsive therapy for epilepsy. The new VNS Therapy system features a wireless wand and new user interface on a small tablet, while the SenTiva device includes detect-and-respond mode designed to prevent seizures before they start and automatically deliver… Mon, 9 Oct 2017 04:00:00 GMT FDA Greenlights Two Generic Glatiramer Acetate Formulations for Relapsing MS The FDA approved Mylan’s generic versions of glatiramer acetate, including a three-times weekly 40mg/mL formulation of glatiramer acetate and a once-daily 20mg/mL formulation. As part of its Abbreviated New Drug Applications, Mylan submitted side-by-side analyses, including characterization data, demonstrating that its formulations have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart Copaxone (Teva). Because Mylan was one of the f… Wed, 4 Oct 2017 04:00:00 GMT US Postal Service Issues Alzheimer’s Disease Semipostal Stamps New stamps for Alzheimer’s disease awareness are coming soon from the US Postal Service. Under its semipostal discretionary program, the Postal Service will issue five stamps over a 10-year period to advance causes it considers to be “in the national public interest and appropriate,” with each stamp to be sold for no more than two years. The Alzheimer’s Semipostal Stamp will be issued during National Alzheimer’s Awareness Month and net proceeds will be distributed t… Mon, 2 Oct 2017 04:00:00 GMT 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 in the US, Canada, Europe, and Australia with a median age of patients was eight years. Following a six-week baseline observation period, patients were randomized to one of three treatment groups: ZX008 0.8mg/kg/day (30mg maximum daily dose), ZX008 0.2 mg/kg/day and placebo in which ZX008 or placebo … Fri, 29 Sep 2017 04:00:00 GMT FDA Approves Intellis Device for Intractable Pain The FDA has approved the Intellis platform (Medtronic) for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems and can power the EvolveSM workflow*, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physician… Wed, 20 Sep 2017 04:00:00 GMT Benefits of PFO Closure Confirmed in Publication of Trial Data Recently published data in The New England Journal of Medicine from three different studies show that closing a patent foramen ovale (PFO) significantly reduces the rate of recurrent stroke compared with medical therapy in patients who experienced a cryptogenic stroke and had a PFO. In the RESPECT study, the Amplatzer PFO Occluder (St. Jude Medical/Abbott Laboratories) was associated with a 45 percent reduction in the risk of ischemic stroke and a 62 percent reduction in the rate of cryptogen… Fri, 15 Sep 2017 04:00:00 GMT Briviact Approved as Monotherapy for Partial-Onset Seizures The FDA has approved a supplemental new drug application for Briviact (brivaracetam, UCB) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy. Briviact is the newest antiepileptic drug in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with… Fri, 15 Sep 2017 04:00:00 GMT Aptiom Approved for Partial-Onset Seizures in Patients Four Years of Age and Older The FDA has approved the supplemental New Drug Application (sNDA) to expand the indication for Aptiom (eslicarbazepine acetate, Sunovion) to include treatment of partial-onset seizures in children and adolescents four to 17 years of age. The approval was based on FDA guidance that permits the extrapolation of data to support pediatric use. The safety and efficacy of APTIOM as monotherapy and adjunctive therapy for the treatment of POS in adults was established in five multicenter, randomized, co… Thu, 14 Sep 2017 04:00:00 GMT 17 New Genes Linked to Parkinson’s Disease A new study has discovered 17 novel genetic variants associated with Parkinson’s disease, several of which are considered targets for intervention. Published in Nature Genetics, the genome-wide association study represents a collaboration between Genentech and the personal genomics company 23andMe. Investigators compared 6,476 PD cases with 302,042 controls as well as a meta-analysis of over 13,000 PF cases, 95,000 controls and 9,830 overlapping variants. Using a neurocentric strategy to a… Thu, 14 Sep 2017 04:00:00 GMT Vitamin D Levels Tied to Risk of MS Examining vitamin D levels in the blood may help predict whether a person is at risk of developing multiple sclerosis (MS), according to a large new study published Neurology (September 13). Using a repository of blood samples from more than 800,000 women in Finland, taken as part of prenatal testing, investigators identified 1,092 women who were diagnosed with MS an average of nine years after giving the blood samples. These samples were compared to those of 2,123 women who did not develop the … Thu, 14 Sep 2017 04:00:00 GMT Blood Test Shown to Accurately Identify Alzheimer’s Disease A blood test may help identify and diagnose Alzheimer’s disease. In a study published in Proceedings of the National Academy of Sciences of the United States of America, researchers used attenuated total reflection FTIR (ATR-FTIR) spectroscopy combined with chemometric techniques to analyze blood plasma samples in 347 individuals with neurodegenerative disease. They identified Alzheimer’s disease with 70% sensitivity and specificity, which after the incorporation of APOE 4 genotype, … Mon, 11 Sep 2017 04:00:00 GMT Project ALS and Amylyx Team Up to Test Phase 2 Compound Project ALS and Amylyx Pharmaceuticals are collaborating to undertake pre-clinical studies to advance the understanding of Amylyx's oral compound AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The studies will be conducted at the Project ALS Pre-Clinical Core at Columbia University's Motor Neuron Center and will complement the company's recently initiated Phase 2 clinical program of AMX0035 for the treatment ALS. The Project ALS Pre-Clinical Core at the Columbia Un… Thu, 7 Sep 2017 04:00:00 GMT 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 to those seen with four years of treatment with cladribine tablets. Published in the Multiple Sclerosis Journal, the data from the CLARITY Extension study assessed annualized relapse rate and confirmed three-month EDSS progression among other efficacy endpoints in 806 patients with relapsing MS. Th… Tue, 5 Sep 2017 04:00:00 GMT Study: Women and Men with APOE Epsilon 4 Gene at Equal Risk for Alzheimer’s Disease Although women with the APOE e3/e4 genotype have been thought to be at greater risk for Alzheimer’s disease, new research suggests that men and women between 55 and 85 years of age with the genotype have nearly the same odds of developing the disease. Reviewing data on nearly 58,000 participants from the Global Alzheimer’s Association Interactive Network, researchers sought to determine the extent to which sex and APOE genotype affect the risks for developing MCI and AD (JAMA Neurol.… Thu, 31 Aug 2017 04:00:00 GMT