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  • Regulatory NewsRegulatory News

    FDA Warns of Rare but Serious Risks Linked to MS Drug Alemtuzumab

    The US Food and Drug Administration (FDA) on Thursday warned that serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Sanofi’s Lemtrada (alemtuzumab). In the nearly five years since FDA approved Lemtrada to treat relapsing forms of MS, the agency said it identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred short...
  • Regulatory NewsRegulatory News

    Congressmen Investigate 'Shadow Pricing' of MS Drugs

    Democratic Reps. Elijah E. Cummings (MD) and Peter Welch (VT) on Thursday sent letters to seven pharmaceutical companies requesting information about the skyrocketing prices for drugs used to treat multiple sclerosis (MS). Cummings and Welch cited an  American Academy of Neurology study  finding that some companies appear to be increasing their prices when competitors do the same, a practice known as "shadow pricing." The study reported that annual MS drug sale...
  • Regulatory NewsRegulatory News

    FDA Considers Label Changes for Keytruda, Opdivo and Yervoy

    The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors. Currently, the labels of Bristol-Myers Squibb’s Yervoy (ipilimumab), Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) have uveitis listed as a potential immune-mediated adverse reaction (AR), and four of the five FDA-approved anti-PD1 therapies’ labels...
  • Regulatory NewsRegulatory News

    EMA Restricts Use of Biogen MS Drug

    The European Medicines Agency (EMA) on Friday announced it is provisionally restricting the use of Biogen Idec’s multiple sclerosis (MS) medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that have failed to respond to other drugs, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.  In addition, EMA said, "patients with liver injury must not be given the medicine. Starting treatment with ...
  • NICE Asks Genzyme for More Cost Effectiveness Data for its MS Drug

    The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), issued draft guidance on 18 September 2013 that requests more data from Genzyme on teriflunomide (Aubagio) as a treatment for adults with relapsing-remitting multiple sclerosis.  The draft noted that the drug is being considered as a first-line treatment option alongside glatiramer acetate and the beta interferons, and administration of the drug would be stopped if the...
  • New Multiple Sclerosis Treatment Wins FDA Approval, Clearing Way for Likely Blockbuster Status

    The US Food and Drug Administration (FDA) has granted approval to Biogen Idec's new multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate capsules), clearing the way for the company to market what some analysts have called a likely blockbuster. The drug is one of several now approved to treat MS, an autoimmune disease of the central nervous system. Other drugs include Novartis' Gilenya, Sanofi's Aubagio, and  Biogen Idec's Tysarbi and Avonex. In a statemen...
  • Multiple Sclerosis Guideline Calls for Adaptive Approaches Based on Risk

    The European Medicines Agency (EMA) has released a draft guideline for the clinical investigation of products intended to treat multiple sclerosis (MS), a neurological disease characterized by the body attacking its own fatty myelin sheaths, disrupting and damaging the body's ability to communicate with itself. The guideline -similar in principle to most released by EMA-establishes a set of recommended approaches to clinical development, with a particular focus on study...
  • New MS Drug Receives FDA Approval

    The US Food and Drug Administration (FDA) has given approval to a new once-a-day drug intended to treat relapsing forms of multiple sclerosis (MS), the agency announced on 12 September. Multiple sclerosis affects the connective tissue around the brain and spine, causing the immune system to attack the body's ability to communicate with itself. Though its causes remain unknown, patients are able to keep the disease in a state of remission through various treatment optio...
  • FDA Issues New Recommendations for MS Drug After Cardiovascular Concerns Raised

    The US Food and Drug Administration (FDA) has placed new contraindications on Novartis' Multiple Sclerosis drug Gilenya (fingolimod) after investigating the cases of several patients who died soon after taking the drug. FDA said it had completed an investigation into the adverse event reports, and while it "could not definitely conclude that Gilenya was related to any of the deaths," it remained "concerned about the cardiovascular effects of Gilenya after the first dose....
  • FDA: Use of Medical Device in MS Patients 'Unproven,' Risky

    The US Food and Drug Administration (FDA) sent out a warning to health professionals on 10 May warning them of the dangers associated with the use of a balloon angioplasty device to widen narrowed veins in the chest and neck of patients suffering from Multiple Sclerosis (MS), saying the procedure was unproven and potentially deadly. The balloon angioplasty devices have been used to experimentally treat chronic cerebrospinal venous insufficiency (CCSVI), which is characte...
  • UK: First Oral Therapy for MS Gets NICE Approval

    In final guidance released 24 April, the UK's National Institute for Clinical Exellence (NICE) recommends that the National Health Service provide Novartis' fingolimod (Gilenya) as long as it gets a special NHS discount from the manufacturer.  Fingolimod is the first pill-based medicine to help reduce the number of relapses for some adults who have highly active relapsing-remitting multiple sclerosis (RRMS) - only if Novartis provides the drug at a confidenti...
  • Novartis Gets Mixed News on MS, HCV Drugs From EMA, FDA

    Swiss pharmaceuticals manufacturer Novartis AG received mixed news from European and American regulators on 18 April, with the European Medicines Agency (EMA) approving its multiple sclerosis drug GIlenya with some additional warnings, and the US Food and Drug Administration (FDA) demanding a phase III trial for its hepatitis C drug alisporivir be halted after safety concerns were raised. EMA's decision on GIlenya came after some concerns about the drug's safety were r...