Generic formulations of dimethyl fumarate — currently sold as Tecfidera by Biogen — were given a green light to enter the U.S. market, after a federal court invalidated a patent protecting Tecfidera from generic competition as a multiple sclerosis (MS) treatment. The ruling by the District Court for the…
treatment
Adamas Pharmaceuticals has decided to stop further clinical development of ADS-5102 (amantadine), intended to help people with multiple sclerosis (MS) who have difficulties with walking. The decision came after the company reviewed findings from a comprehensive analysis of…
A person infected through the skin by the hookworm Necator americanus shows a spike in regulatory T-cells, specialized immune T-cells that work to limit inflammation, and a controlled infection by these generally safe worms may benefit some relapsing multiple sclerosis (MS) patients, research suggests. “The…
Gilenya (fingolimod), which works to modulate immune system activity in multiple sclerosis (MS), may benefit people with severe respiratory disease associated with COVID-19, a case report highlights. The study, “Severe COVID-19 infection in a patient with multiple sclerosis treated with fingolimod,” was published in…
Atara Biotherapeutics has enrolled a first patient in a clinical trial testing ATA188, its off-the-shelf T-cell immunotherapy for people with progressive forms of multiple sclerosis (MS). The Phase 1b trial (NCT03283826) follows promising safety and tolerability results from its open-label Phase 1a part, including a…
Nearly 3,000 multiple sclerosis (MS) healthcare providers and researchers convened recently to share their findings regarding the latest developments in the diagnosis and treatment of MS. However, unlike past meetings, this year’s 34th Annual Meeting of the Consortium of MS Centers (CMSC) took place online. Virtual presentations covered the…
Australian scientists have discovered subsets of immune cells that differ between people who have multiple sclerosis (MS) and those who don’t. Because the prevalence of these cells correlates with autoimmune attacks, they represent potential targets for MS therapies. The study, “IgG3 + B…
Mapi Pharma, supported by an additional $20 million investment from its partner Mylan, will continue a Phase 3 trial assessing the safety, tolerability, and efficacy of GA Depot, its long-acting, once-a-month injectable formulation of glatiramer acetate. The study (NCT04121221), which opened in October 2019,…
Five people with multiple sclerosis (MS) who tested positive for COVID-19 while being treated with Aubagio (teriflunomide) all developed a mild infection, had good outcomes, and experienced no disease relapses, a case study reported. These findings suggest that use of Aubagio, a disease-modifying therapy that acts on the immune system,…
Autobahn Therapeutics announced its launch with $76 million in financing to support work on therapies for central nervous system (CNS) disorders, including ABX-002, its lead candidate to treat diseases marked by the loss of myelin, such as …
The risk of a relapse is two to three times higher in relapsing-remitting multiple sclerosis (RRMS) patients who switch from Tysabri (natalizumab) to an oral or other injectable…
After repeated exposure to a fragment of the myelin protein — the target of autoimmune attack in multiple sclerosis (MS) — immune cells in mice were reprogrammed to be tolerant to myelin, suppressing the immune response associated with the disease, a study revealed. Researchers showed that in these…
Note: This story was updated on June 15, 2020, to clarify that the agreement allows for possible reimbursement for Prime’s health plan clients, not patients directly. Prime Therapeutics has signed an agreement with EMD Serono that may provide financial compensation for its health plan clients if their members…
By my unofficial count, disease-modifying therapy No. 19 has just become available to people with multiple sclerosis in the U.S. The U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) in late March. While pharmaceutical companies usually rush to make newly approved medications available to patients, with COVID-19 raging,…
Tweaking the protective properties of the gut mucus, a layer lining the inside of the gut, to boost the proliferation of good bacteria potentially could halt the development of neurological disorders, like multiple sclerosis (MS), according to a review of more than 100 studies. The review, “…
The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘ ofatumumab, a possible self-administered injection therapy for relapsing multiple sclerosis (MS), the company announced. Originally expected in June, the FDA decision is now expected in September. “Novartis will continue to work with the FDA to…
Zeposia (ozanimod), a newly approved oral capsule treatment for relapsing forms of multiple sclerosis (MS), is now commercially available in the United States, its manufacturer, Bristol Myers Squibb, announced. “We are pleased to now bring Zeposia, an important new once daily treatment option, to [relapsing]…
A clinical trial testing Midamor (amiloride), Prozac (fluoxetine), and riluzole in people with secondary progressive multiple sclerosis (SPMS) failed to find a treatment benefit for any of the…
The European Medicines Agency (EMA) approved a shorter infusion time for Ocrevus (ocrelizumab), an approved treatment for people with relapsing or primary progressive multiple sclerosis (MS). The approval follows a positive recommendation from EMA’s Committee for Medicinal Products for Human Use (CHMP),…
Atara Biotherapeutics‘ cell-based therapy ATA188 is safe and well-tolerated in people with progressive forms of multiple sclerosis (MS), and induces a sustained reduction in disability in a dose-dependent manner, findings from the first part of a Phase 1 clinical trial show. ATA188 had an…
Ofatumumab (OMB157) elicits a strong and fast reduction in the levels of circulating immune cells in people with relapsing forms of multiple sclerosis (MS), effectively helping to stop disease activity, according to new data from the Phase 2 APLIOS trial. The medication was also found to be more…
The European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease based on clinical or imaging features. The EC decision follows a positive opinion issued in March by the European Committee for Medicinal Products for Human Use (CHMP).
Note: This story was updated May 27, 2020, to note a change in the protocol of the EVOLUTION trials, which are now comparing evobrutinib with Aubagio, rather than Avonex, along with updated NCT numbers. The investigational oral medication evobrutinib leads to a sustained reduction in relapse rates…
Human glial progenitor cells — forerunners of nerve cells that protect and support neurons — transplanted into adult mice in a model of multiple sclerosis (MS) were seen to restore myelin production and motor function in the animals. This study and others it builds on “establish an operational…
Movements that are an act of “learning” motor tasks after lesions appear in the protective myelin sheath of neurons seem to induce both new and existing oligodendrocytes — the cells that make up myelin — to repair those lesions, a study in mice shows. Precisely timed rehabilitation programs and exercise may…
Glatopa, a generic form of Copaxone, is as effective as the brand-name medication in terms of disease outcomes and has similar healthcare-related costs in real-world use in patients with relapsing multiple sclerosis (MS), a new U.S. study suggests. Data also suggest a trend toward lower relapse rates with Glatopa…
Targeting the MOSPD2 protein may prevent immune cells known as monocytes from entering the central nervous system (CNS), which may significantly ease brain inflammation and myelin damage in multiple sclerosis (MS), a study in mice suggests. VBL Therapeutics, the company leading the study, has developed…
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Helius Medical Technologies’ portable neuromodulation stimulator (PoNS) for the treatment of walking impairments in multiple sclerosis (MS) patients. The device, which is meant to be used…
Sativex (nabiximols) eases spasticity-associated symptoms in multiple sclerosis (MS) patients, including those with no significant improvements in a validated spasticity scale, according to a large study from Italy. The findings support previous studies suggesting that spasticity scales may not be enough to evaluate patients’ responses to Sativex and to…
FDA Approves Bafiertam, Tecfidera Bioequivalent, for Relapsing MS This is the second disease-modifying therapy (DMT) OK’d by the FDA in the past few months. Bafiertam is a delayed-release pill that’s similar to Tecfidera, but it’s said that it has fewer side effects. Unfortunately, its manufacturer hasn’t yet made it…
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