January 7, 2019 News by Alice Melão, MSc More Effort Needed to Recruit Minorities to Phase 3 Clinical Trials, MS Expert Says Because multiple sclerosis (MS) presentation and progression course can be very different between people of African ancestry and Caucasians, the recruitment of minorities to Phase 3 clinical trials is of particular importance. Researchers in the MS field and the general MS community should make a greater effort to improve…
December 20, 2018 News by Alice Melão, MSc Cannabis-based Sublingual Tablet to Enter Trials in Israel as Possible Spasticity Treatment, OWCP Says OWC Pharmaceutical Research is planning new clinical studies to evaluate the activity and safety of its cannabinoid-enriched sublingual soluble tablet. The company announced that an Institutional Review Board (IRB) in Israel approved its request to conduct a safety and tolerability trial there. The company also is asking to amend the…
December 18, 2018 News by Alice Melão, MSc FDA Asked to Approve Diroximel Fumarate as Oral Treatment for Relapsing MS Alkermes filed a request for the approval of diroximel fumarate (BIIB098) to treat relapsing forms of multiple sclerosis (MS) with the U.S. Food and Drug Administration (FDA). If approved, diroximel fumarate will be marketed by Biogen in the U.S., likely under the brand name Vumerity. Alkermes and Biogen are working…
December 12, 2018 News by Alice Melão, MSc Ocrevus Now Available Through NHS Scotland to Treat RRMS Ocrevus (ocrelizumab, by Genentech) is now available through the National Health System (NHS) of Scotland to treat patients with relapsing-remitting multiple sclerosis (RRMS). The decision by the Scottish Medicines Consortium (SMC) to approve Ocrevus’ inclusion for this patient group follows the recommendation made earlier by the U.K.’s…
December 11, 2018 News by Alice Melão, MSc WUSTL Team Receives $6.3 Million Grant to Develop PET Scan Tracers The Washington University School of Medicine in St. Louis (WUSTL) will create a new research center to investigate and advance the development of tracers for positron emission tomography (PET) scans. The center, which will be established at WUSTL’s Mallinckrodt Institute of Radiology (MIR), is going to focus on the…
November 30, 2018 News by Alice Melão, MSc Gilenya Now Approved in Europe to Treat Children, Adolescents with RRMS Gilenya (fingolimod) was approved by the European Commission as a treatment for children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS), Novartis announced. The therapy is already approved in Europe to treat RRMS patients 18 and older. With this newest decision, Gilenya has become…
November 28, 2018 News by Alice Melão, MSc Artificial Intelligence May Help Reduce Dosage of Gadolinium in MRIs, Researchers Suggest Artificial intelligence can help reduce the amount of gadolinium used as a contrast agent in MRI (magnetic resonance imaging) scans, preventing the agent’s potential toxicity when accumulated in body tissue, including the brain and bones, each time it is used, researchers suggest. The finding is of particular importance for…
November 21, 2018 News by Alice Melão, MSc Phase 2 Trial of NurOwn Stem Cell Therapy in Progressive MS Planned for US, BrainStorm Announces BrainStorm Cell Therapeutics is planning to launch a Phase 2 clinical trial in the United States to evaluate the safety and activity of its lead cell therapy candidate, NurOwn, in people with progressive multiple sclerosis (MS). The company announced that has submitted an Investigational New Drug (IND) application to…
November 20, 2018 News by Alice Melão, MSc FDA Approves Generic Version of Aubagio to Treat Relapsing MS, Glenmark Pharma Says The U.S. Food and Drug Administration (FDA) has approved a generic version of  Aubagio (teriflunomide) tablets at the 7 mg and 14 mg doses marketed by Sanofi, according to the generic’s manufacturer, Glenmark Pharmaceuticals. The FDA’s decision to approve the company’s application for teriflunomide tablets at two…
November 1, 2018 News by Alice Melão, MSc Protein Produced by Common Gut Bacteria Can Trigger Autoimmunity, Study Suggests Bacteria that reside in human gut may trigger autoimmune reactions by producing human-like proteins that mimic a naturally occurring and crucial cell protein. Researchers at Queen’s University Belfast in Ireland report that patients with autoimmune disorders — such as multiple sclerosis (MS), rheumatoid arthritis, and ulcerative colitis — have…
October 29, 2018 News by Alice Melão, MSc Mavenclad Named ‘Rapid Uptake Product’ in UK with Goal of Speeding Its Availability in NHS Mavenclad (cladribine tablets, 10 mg) was one of the seven medicinal and medical technology products selected by the Accelerated Access Collaborative (AAC) as a “rapid uptake product” — a U.K. recognition that aims to bring life-changing technologies into the country’s National Health System (NHS), and to patients,…
October 25, 2018 News by Alice Melão, MSc Stem Cells from MS, Parkinson’s Patients Voyaging to Space Station to Study Disease Impact on Brain in Microgravity Stem cells from patients with Parkinson’s disease and primary progressive multiple sclerosis (PPMS) are soon to voyage into space, and be brought aboard the International Space Station so cell-to-cell interactions in these neurodegenerative diseases can be studied without gravitational forces acting on them. This research project, proposed to launch in May…
October 19, 2018 News by Alice Melão, MSc Enzyme Produced by Gut Bacteria Linked to T-cell Attacks on Myelin in Study An enzyme produced by bacteria in the gut was seen to activate immune cells linked to the development and progression of multiple sclerosis, a finding that may pave the way for a vaccine that might alter autoimmune mechanisms involved in MS. The study, “…
October 18, 2018 News by Alice Melão, MSc #ECTRIMS2018 – Role of Brain Atrophy in MS Progression Poorly Understood by Patients, MSAA Survey Finds Although brain atrophy — the loss of brain volume — is an increasingly important measure in multiple sclerosis trials and treatment outcomes, MS patients have a limited understanding of its role in disease progression, a survey reveals. This finding was detailed in the presentation “…
October 15, 2018 News by Alice Melão, MSc #ECTRIMS2018 – Additional Analysis on Ozanimod Demonstrates Its Potential to Treat Relapsing MS Additional analysis of clinical data from Celgene’s investigational agent ozanimod continues to demonstrate its potential to benefit patients with relapsing multiple sclerosis (MS). Findings from the Phase 3 SUNBEAM and RADIANCE Part B trials were discussed at the 34th Congress of the European Committee for Treatment and…
October 12, 2018 News by Alice Melão, MSc #ECTRIMS2018 – MS Patients More Prone to Health Problems Before, After Diagnosis, Study Suggests Patients with multiple sclerosis (MS) are more likely to experience health problems before they receive their formal diagnosis, as well as to experience serious non-MS-related complications after diagnosis, a study reveals. The findings were reported in the study “Increased risk of…
October 10, 2018 News by Alice Melão, MSc #ECTRIMS2018 — Merck KGaA to Present Latest Data on MS Portfolio Merck KGaA will present the latest advances made on several of its therapies aiming to treat multiple sclerosis (MS) at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS). The conference is taking place through Friday in Berlin. The company, known as…
October 10, 2018 News by Alice Melão, MSc FDA, EMA Agree to Review Novartis Therapy Siponimod to Treat SPMS Novartis is seeking U.S. and European approval of its investigational oral agent siponimod to treat adults with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application, while the European Medicines Agency (EMA) has accepted for review…
October 8, 2018 News by Alice Melão, MSc UVA Scientist Awarded $5.6M by NIH to Further Study Lymph System and Brain Connection Jonathan Kipnis, the researcher who discovered that lymphatic vessels are important mediators of the underlying molecular mechanism of multiple sclerosis (MS), has received the prestigious Director’s Pioneer Award from the National Institutes of Health (NIH). This prize recognizes researchers who have made important contributions to the development of new…
September 26, 2018 News by Alice Melão, MSc Nyrada Identifies Novel IRAK4 Inhibitors that May Prevent Neuroinflammation Nyrada, a subsidiary company of Noxopharm, discovered a set of novel compounds that can cross the blood-brain barrier and blood-nerve barriers, and inhibit a master regulator of chronic inflammation in autoimmunity called IRAK4. The Australian company believes that these novel IRAK4 inhibitors may represent an alternative strategy to…
September 21, 2018 News by Alice Melão, MSc Ocrevus Climbing as First-line DMT for RRMS Among Neurologists Surveyed in Spherix Report Eighteen months after its entrance into the U.S. market, Genentech’s Ocrevus (ocrelizumab) has become the monoclonal antibody of choice to treat patients with multiple sclerosis (MS), according to a survey of nearly 100 neurologists across the U.S. Self-reported use of Ocrevus for the third quarter of 2018 surpassed…
September 5, 2018 News by Alice Melão, MSc Mavenclad Approved to Treat Highly Active Relapsing MS Patients in Ireland Adults in Ireland with highly active relapsing multiple sclerosis (MS) now can be treated with Mavenclad (cladribine tablets, 10 mg), the first short-course oral treatment approved for this disease. The Irish Health Service Executive (HSE) has approved this new therapy and decided to reimburse patients for its associated…
August 8, 2018 News by Alice Melão, MSc Quanterix’s Simoa Assay May Make Neurofilament Light Chain Useful Blood Biomarker of MS and Its Likely Progression Quanterix’s ultra-sensitive Simoa assay has the potential to open new uses for the brain biomarker known as neurofilament light chain, including the possibility to detect early evidence of neurological diseases like multiple sclerosis (MS), Parkinson’s, and Alzheimer’s, and ably evaluate efforts to treat and prevent them, the company…
August 2, 2018 News by Alice Melão, MSc Potential B-cell Targeting Oral MS Treatment, PRN2246, Shows Ability to Reach Brain in Phase 1 Study Results from a first-in-human study assessing the safety and early activity of PRN2246 confirmed that the oral compound can reach into the brain and spinal cord. This finding adds new evidence that PRN2246 has the potential to target the immune cells that drive the inflammatory process involved in multiple sclerosis…
July 31, 2018 News by Alice Melão, MSc FDA to Review EMD Serono’s New Request for Approval of Cladribine for Treating Relapsing MS Seven years after it first denied the request, the U.S. Food and Drug Administration accepted for review EMD Serono’s resubmitted New Drug Application (NDA) for cladribine tablets (brand name Mavenclad) as a treatment for patients with relapsing forms of multiple sclerosis (MS). The regulatory agency agreed EMD…
July 27, 2018 News by Alice Melão, MSc Oral DMTs Still Common 1st Therapy for New MS Patients but Ocrevus Having Impact, Market Report Says Oral disease-modifying therapies (DMTs) are the most common first choice of treatment for people newly diagnosed with multiple sclerosis (MS) in the United States, an analysis reports. Antibody-based DMTs like Ocrevus, however, are emerging competitors. Spherix Global Insights, a market research and analysis company, states that 1 in every…
July 24, 2018 News by Alice Melão, MSc Enzyme Key to Myelin Renewal and Nerve Cell Health Possibly Identified in Study A better understanding of the processes behind a continual and healthy renewal of myelin — the fatty, protective substance wrapping nerve cell fibers — may now exist. Researchers identified an enzyme, called PRMT5, that they believe regulates the number of myelin-producing cells in the brain and spinal cord. Their discovery…
July 17, 2018 News by Alice Melão, MSc Progressive MS Patients with Considerable Disability Ably Treated with Cladribine, UK Case Study Reports Cladridine may be effective in preventing disability progression and reducing damage to nerve cells in people with progressive forms of multiple sclerosis (MS), researchers suggest based on a case study of two such patients given the injectable treatment. MS is characterized by progressive degeneration of cells in the central nervous system, mostly…
July 13, 2018 News by Alice Melão, MSc Common Anti-Parasitic Agent Eases Motor Symptoms, Aids Remyelination in MS Mouse Model A common anti-parasitic agent showed a potential to prevent inflammation and to promote nerve cell recovery — remyelination — in a mouse model of multiple sclerosis (MS). By promoting the activity of a receptor called P2X4R that is present in microglial cells — immune cells that reside in the brain…
July 3, 2018 News by Alice Melão, MSc No Risk of MS Found in GlaxoSmithKline Vaccine for Swine Flu, Canadian Study Says Protecting the public against an outbreak like the swine flu using GlaxoSmithKline‘s vaccine Arepanrix — or a similar vaccine with an AS03 adjuvant delivery system — does not increase a risk of multiple sclerosis (MS), a population study conducted in Canada reports. The study, “Registry Cohort Study to Determine Risk…