Biogen

Aptar to operate, develop Biogen’s lifestyle support apps for MS

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…

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The European Commission (EC) has withdrawn its marketing authorizations for generic versions of Tecfidera (dimethyl fumarate), an oral therapy approved in Europe for relapsing-remitting multiple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 to Biogen, which developed and markets the brand-name medication, the decision ensures Biogen will have full data and marketing protection…

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…

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,…

Biogen, MedRhythms Working on Music Therapy for MS Gait Issues

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…

Vumerity Added to NHS of England for People With Active RRMS

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…

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 Scotland’s National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…

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 country’s national health service (NHS). The poor cost-effectiveness of Fampyra — sold…

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…

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…

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 sclerosis (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…

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…

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, 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…

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 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…