February 14, 2024 News by Mary Chapman Aptar to operate, develop Biogen’s lifestyle support apps for MS Under a new agreement, Biogen is transferring ownership of certain digital health solutions ā including two existing mobile applications, or apps, offering lifestyle support to people with multiple sclerosis (MS) ā to Aptar Digital Health. The collaboration calls for Aptar, part of AptarGroup, to handle product design…
January 17, 2024 News by Andrea Lobo, PhD Acorda taking over global marketing of Fampyra, MS walking aid 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…
December 22, 2023 News by Mary Chapman Generics of Tecfidera not available in Europe until at least 2025 The European Commission (EC) has withdrawn its marketing authorizations for generic versions of Tecfidera (dimethyl fumarate), an oral therapy approved in Europe for relapsing-remitting multiple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 toĀ Biogen, which developed and markets the brand-name medication, the decision ensures Biogen will have full data and marketing protection…
April 14, 2023 Columns by Ed Tobias Will layoffs at Biogen affect its focus on multiple sclerosis treatments? 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…
September 9, 2022 News by Marisa Wexler, MS Tysabri Improves Cognition Over Long-term in Early RRMS Patients 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…
September 8, 2022 News by Marisa Wexler, MS High-efficacy DMTs Boost Mid-term Prognosis for Relapsing MS: Study 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,…
August 9, 2022 News by Lindsey Shapiro, PhD Tysabri Beats Other DMTs in Helping With Symptoms, Work Productivity 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…
June 23, 2022 News by Marta Figueiredo, PhD Biogen Secures Tecfidera Patent in EU Until 2028; Generics Not Likely Biogen has secured a new patent in Europe covering the use of its oral therapy TecfideraĀ (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…
May 18, 2022 News by Lindsey Shapiro, PhD Gilenya, Tysabri Show Superiority at Preventing Relapses in Children 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…
May 16, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: Music, Resilience, Childhood Abuse, Exercise 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…
May 10, 2022 News by Marta Figueiredo, PhD Biogen, MedRhythms Working on Music Therapy for MS Gait Issues Biogen has entered a licensing agreementĀ to develop and potentially commercialize MedRhythms‘Ā investigational music-based digital therapy, MR-004, designed to help make walking easier for people with multiple sclerosis (MS). The partnership combines Biogenās leadership and expertise in MS with MedRhythmsā digital therapeutics platform that uses sensors, algorithms, and music…
May 3, 2022 News by Marisa Wexler, MS Tysabri Every 6 Weeks Found as Effective as Standard 4-week Dosing 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…
April 25, 2022 News by Marta Figueiredo, PhD Plegridy Found at Minimal Levels in Breast Milk, Small Study Reports 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 EuropeĀ and…
April 14, 2022 News by Marisa Wexler, MS Vumerity Added to NHS of England for People With Active RRMS The National Institute for Health and Care Excellence (NICE) has added oralĀ Vumerity (diroximel fumarate), approved to treatĀ relapsing-remitting multiple sclerosisĀ (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…
February 9, 2022 News by Marisa Wexler, MS Vumerity Added to NHS of Scotland for People With Active RMMS 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 Scotlandās National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…
February 8, 2022 News by Marisa Wexler, MS Patients Who Stop Tysabri for Pregnancy at Higher Risk for Relapse 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…
January 10, 2022 News by Lindsey Shapiro, PhD After Tysabri, Ocrevus Seen as Better Than Gilenya at Preventing Relapse 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 āpotentially a better exit strategy than [Gilenya] after [Tysabri] cessation, with an impressive reduction [in] risk…
December 20, 2021 News by Marta Figueiredo, PhD NICE Still Opposes Adding Fampyra to NHS for England 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 countryās national health service (NHS). The poor cost-effectiveness of Fampyra ā sold…
November 17, 2021 News by Marisa Wexler, MS Vumerity Approved for RRMS in European Union 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…
October 15, 2021 News by Marisa Wexler, MS #ECTRIMS2021 ā Lower Relapse Rates Seen With Tysabri Than Ocrevus Editorās note: TheĀ 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. 13ā15. GoĀ here to see the latest stories from the conference. People withĀ …
October 1, 2021 Columns by Ed Tobias Humana’s Lawsuit Against Biogen Decries Ongoing ‘Seed and Sweep’ Schemes 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…
September 30, 2021 News by Marisa Wexler, MS Oct. 4 Online Conference Offers Latest Insights Into Progressive MS 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…
September 20, 2021 News by Marisa Wexler, MS Vumerity Recommended for EU Approval as RRMS Treatment 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 sclerosisĀ (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
August 3, 2021 News by Steve Bryson, PhD Tysabri Safe and Effective Taken Every 6 Weeks, NOVA Trial Finds 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…
July 30, 2021 Columns by Ed Tobias Could BTK Inhibitors Be the Next Big MS Treatment? 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…
July 19, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: Orelabrutinib, MS Stress, Selma Blair 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…
July 14, 2021 News by Marta Figueiredo, PhD Biogen Strikes Deal for Orelabrutinib, Now in Phase 2 Trial Biogen has signed a deal with InnoCare Pharma to acquire global commercialization and licensing rights to orelabrutinib, anĀ 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…
June 3, 2021 News by Aisha I Abdullah PhD NfL Promising Biomarker for Predicting Tecfidera Response 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…
April 30, 2021 News by Forest Ray PhD FDA Rejects Under-the-skin Tysabri for Relapsing MS The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of TysabriĀ (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…
April 28, 2021 News by Forest Ray PhD #AANAM ā Vumerity Showing Tolerability, Efficacy in Ongoing EVOLVE-MS-1 Trial Editorās note: TheĀ Multiple Sclerosis News TodayĀ team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17ā22. GoĀ hereĀ 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…