Under a new agreement, Biogen is transferring ownership of certain digital health solutions — including two existing mobile applications, or apps, offering lifestyle support to people with multiple sclerosis (MS) — to Aptar Digital Health. The collaboration calls for Aptar, part of AptarGroup, to handle product design…
Biogen
Fampyra (fampridine), an approved oral treatment to improve the walking abilities of adults with multiple sclerosis (MS), soon will be sold by Acorda Therapeutics worldwide. The announcement follows the decision by Biogen to terminate a licensing agreement that gave it global development and marketing rights…
The European Commission (EC) has withdrawn its marketing authorizations for generic versions of Tecfidera (dimethyl fumarate), an oral therapy approved in Europe for relapsing-remitting multiple sclerosis (RRMS). According to Biogen, which developed and markets the brand-name medication, the decision ensures Biogen will have full data and marketing protection…
Biogen has been a top dog in the multiple sclerosis (MS) treatment field for decades. The pharmaceutical giant developed Avonex (interferon beta-1a), approved in the U.S. in 1996 as one of the first disease-modifying therapies (DMTs) for MS. I remember how excited I was to be…
Long-term treatment with Tysabri (natalizumab) significantly improves cognitive function and increases the chance of disability reduction in people with early relapsing-remitting multiple sclerosis (RRMS), according to data from the four-year observational STRIVE trial. Patients on Tysabri also reported improved quality of life and less impact of MS on…
People with relapsing multiple sclerosis (MS) treated with Tysabri (natalizumab) or Gilenya (fingolimod) are less likely to have disease activity than those on low-efficacy MS medications, according to a small study conducted in Japan. Results also showed that patients receiving the high-efficacy therapies had less brain shrinkage,…
Tysabri (natalizumab) outperforms other disease-modifying therapies (DMTs) in its ability to lessen a range of patient-reported symptoms in people with multiple sclerosis (MS), according to data from a large real-world study. These symptoms include balance difficulties, sensory problems, feelings of anxiety, bladder problems, vision problems, and…
Biogen has secured a new patent in Europe covering the use of its oral therapy Tecfidera (dimethyl fumarate) for multiple sclerosis (MS) through 2028, the company announced. Granted by the European Patent Office, patent EP2653873 covers the composition and use of dimethyl fumarate at a dose of 480…
Gilenya (fingolimod) and Tysabri (natalizumab) were more effective at lowering relapse rates in children with multiple sclerosis (MS) than interferon-beta, according to a recent meta-analysis. Findings like these can be leveraged for better clinical trial design, the researchers wrote. If used to determine “historical” relapse rates that…
Biogen, MedRhythms Working on Music Therapy for MS Gait Issues This is music to my ears. Sorry, I couldn’t resist, but I’m a big music fan. Music in my ears really motivates me when I’m exercising. So the idea of using computer-based music therapy to improve someone’s gait has…
Biogen has entered a licensing agreement to develop and potentially commercialize MedRhythms‘ investigational music-based digital therapy, MR-004, designed to help make walking easier for people with multiple sclerosis (MS). The partnership combines Biogen’s leadership and expertise in MS with MedRhythms’ digital therapeutics platform that uses sensors, algorithms, and music…
Tysabri (natalizumab) given every six weeks was found to be similarly effective as the standard four-week dosing schedule at stopping nervous system damage in people with relapsing-remitting multiple sclerosis (RRMS). That’s according to the full results of the Phase 3b NOVA clinical trial, which compared Tysabri dosing schedules…
Plegridy (peginterferon beta-1a), an approved treatment for relapsing multiple sclerosis (MS), is detected at minimal concentrations in the breast milk of patients using the therapy postpartum, a small study showed. This is in line with label updates on Plegridy and other interferon beta therapies in Europe and…
The National Institute for Health and Care Excellence (NICE) has added oral Vumerity (diroximel fumarate), approved to treat relapsing-remitting multiple sclerosis (RRMS) in the U.K., to the list of medications available through the public health program for England. Because the therapy has been recommended through a fast track appraisal process, Vumerity…
Note: An earlier version of this story stated the Scottish Medicines Consortium approved Vumerity for RRMS patients in that country. The consortium decides to add a medicine to Scotland’s National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…
The majority of multiple sclerosis (MS) patients who stop taking Tysabri (natalizumab) before or when they become pregnant experience a disease relapse during pregnancy or shortly thereafter, according to a study out of Germany. In more than one out of every 10 cases, relapses were so severe that…
Ocrevus (ocrelizumab) may be more effective than Gilenya (fingolimod) at preventing relapse in relapsing-remitting multiple sclerosis (RRMS) patients who recently transitioned from Tysabri (natalizumab), according to a new study. Ocrevus is “potentially a better exit strategy than [Gilenya] after [Tysabri] cessation, with an impressive reduction [in] risk…
The National Institute for Health and Care Excellence (NICE) in England is set to again recommend against adding Fampyra (fampridine) to the list of medications available to multiple sclerosis (MS) patients with walking difficulties through the country’s national health service (NHS). The poor cost-effectiveness of Fampyra — sold…
The oral medication Vumerity (diroximel fumarate) has been approved by the European Commission to treat adults with relapsing-remitting multiple sclerosis (RRMS). “This approval is a significant step forward in improving treatment adherence for people living with relapsing MS, which can make a meaningful difference on treatment…
Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13–15. Go here to see the latest stories from the conference. People with …
People living with multiple sclerosis know that the medications used to treat it are expensive. According to the National Multiple Sclerosis Society, the median annual price of brand-name disease-modifying therapies (DMTs) last year was $91,835. Five of them carried a price tag of more than $100,000 a year. Many pharmaceutical…
An upcoming conference focused on progressive multiple sclerosis (MS) will offer the latest insights about the underlying biology of the disease, and treatment and clinical strategies in development. The one-day conference, “Emerging Research & Trial Strategies for Progressive Multiple Sclerosis,” is taking place virtually on Oct. 4,and is…
A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
Tysabri (natalizumab) given every six weeks was as safe and effective over nearly 1.5 years of use as its approved four-week dosing in people with relapsing-remitting multiple sclerosis (RRMS), according to top-line data from the Phase 3b NOVA study. Tysabri is typically administered every four weeks, or about…
Is orelabrutinib one of the next big MS therapies? Biogen is betting at least $125 million that it is. Orelabrutinib is an experimental oral BTK inhibitor (BTKi). BTKi’s are designed to selectively block an enzyme that’s important for the activation of B-cells and microglia. Some of those immune cells…
Biogen Strikes Deal for Orelabrutinib, Now in Phase 2 Trial BTK inhibitors, such as orelabrutinib, are designed to selectively block the activity of an enzyme important for the activation of B-cells and microglia. Some of those cells drive the abnormal immune responses that attack the central nervous systems of…
Biogen has signed a deal with InnoCare Pharma to acquire global commercialization and licensing rights to orelabrutinib, an experimental oral BTK inhibitor (BTKi) now being tested in people with relapsing-remitting multiple sclerosis (RRMS) in a Phase 2 clinical trial. Under the terms of the agreement, Biogen will have…
Low levels of serum neurofilament light chains (sNfL) prior to treatment predicts an optimal response to Tecfidera (dimethyl fumarate) and reduced immune cell overactivity in multiple sclerosis (MS) patients, a study reports. The investigators noted the…
The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of Tysabri (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). “This response from the FDA does not affect the intravenous administration of Tysabri, a well-established high-efficacy treatment with a…
Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Vumerity (diroximel fumarate) continues to be safe and well-tolerated, in addition to reducing measures of disease activity in people…