Tiziana Life Sciences‘ intranasal spray foralumab continues to be safe and well-tolerated, with no drug-related serious side effects reported after long-term use, according to an annual report filed with the U.S. Food and Drug Administration (FDA). The company is developing foralumab for neuroinflammatory diseases such as multiple…
Drug information
Gadoquatrane, a contrast agent Bayer is developing for MRI scans, showed similar safety and pharmacokinetic (PK) profiles — meaning how a drug moves into, through, and out of the body — in both children and adults. That’s according to data from the Phase 3 QUANTI Pediatric study (NCT05915026),…
Tyruko (natalizumab-sztn) is now commercially available in the U.S. as the first and only approved biosimilar to Tysabri for adults with relapsing forms of multiple sclerosis (MS). The therapy received approval from the U.S. Food and Drug Administration (FDA) in 2023 for all indications covered by the…
A generic formulation of Zeposia (ozanimod), which won tentative approval for treating multiple sclerosis (MS) from the U.S. Food and Drug Administration (FDA), will be manufactured and supplied by Synthon, based in the Netherlands. Tentative approval means the generic version has met all FDA requirements for…
Three biosimilar drugs — approved versions of brand-name therapies that have no clinically meaningful differences compared with their reference products — including one for multiple sclerosis (MS), will soon be available in the Middle East and North Africa (MENA) region under a new partnership between two pharmaceutical companies.
In the U.S., nearly 4 out of 5 neurologists prescribing therapies for multiple sclerosis (MS) have received payments from pharmaceutical companies that market MS treatments, according to a new analysis. The findings indicate that neurologists who receive payments from a company are significantly more likely to prescribe that…
Health Canada is warning that glatiramer acetate products, used in the country to treat relapsing-remitting multiple sclerosis (MS), may cause a severe allergic reaction called anaphylaxis, which can be life-threatening. The warning follows 11 reported cases of anaphylactic reactions linked to Copaxone — the original brand name of glatiramer…
A generic version of Ampyra (dalfampridine), used to improve walking in adults with multiple sclerosis (MS), is now available in the U.S. at a price its developer said is almost $1,000 a month lower than average. Civicascript will charge pharmacies $16 for each 60-tablet bottle, and recommends…
Alvotech, a developer of biosimilar medicines, is expanding its partnership with Advanz Pharma to commercialize three new products in Europe — one of them a biosimilar of Kesimpta (ofatumumab), a drug used for treating multiple sclerosis (MS). Biosimilars are therapies that have no clinically meaningful differences…
People with multiple sclerosis (MS) may receive less frequent infusions of rituximab without increasing their chances of relapse or disease progression, according to a real-world study from Norway. After receiving three doses at six-month intervals, extending the time between following doses to nine months is “a safe and effective…
The U.S. Food and Drug Administration (FDA) has added a new boxed warning to the prescribing information for glatiramer acetate, an approved injection therapy for relapsing forms of multiple sclerosis (MS) that’s sold under the brand name Copaxone and is also available as generic products. A boxed warning…
Treatment with Tecfidera (dimethyl fumarate) significantly reduces relapse rates for people with multiple sclerosis (MS), and most MS patients on the approved therapy remain free from disability progression for several years. That’s according to a final analysis from the Phase 4 ESTEEM clinical trial (NCT02047097), which tracked…
Fampyra (fampridine), an oral medication that’s approved to improve walking ability in adults with multiple sclerosis (MS), may also help some people with poor working memory, according to a new study. Working memory refers to a person’s ability to keep small pieces of information at the forefront of…
The European Commission (EC) fined Teva Pharmaceuticals €462.6 million — more that $502 million — after an investigation it launched found the company illegally tried to stop competitor versions of Copaxone (glatiramer acetate injection), its blockbuster drug for multiple sclerosis (MS), from entering markets. Several patents…
People with multiple sclerosis (MS) and other conditions who use Mallinckrodt‘s treatment Acthar Gel (repository corticotropin injection) now have a self-injection option, the company said. Acthar Gel Single-Dose Pre-filled SelfJect is available in two dosages — 40 USP units/0.5 ml and 80 USP units/1.0 mL — that…
People with multiple sclerosis (MS) who are being treated with Tysabri (natalizumab) tend to prefer receiving the medication as a subcutaneous (under-the-skin) injection rather than an intravenous (into-the-vein) infusion, according to new data from an observational study. “Based on current data, there is a trend toward patients’ preference…
Viatris has launched a generic version of low-dose Copaxone (glatiramer acetate) in the Canadian market for the treatment of people with relapsing-remitting multiple sclerosis (RRMS) who retain the ability to walk. Called Glatiramer Acetate Injection 20 mg/mL, the product was approved in Canada as a generic of…
The U.S. Patent and Trademark Office (USPTO) has notified Vanda Pharmaceuticals that it will grant a new patent covering the use of Ponvory (ponesimod), an approved oral treatment for relapsing forms of multiple sclerosis (MS), that will span nearly two decades, the company announced. The upcoming patent specifically…
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…
Vanda Pharmaceuticals has acquired the U.S. and Canadian rights to Ponvory (ponesimod), an oral therapy approved for relapsing types of MS, in a new deal with Actelion Pharmaceuticals. Under the terms of the agreement, Vanda paid $100 million to Actelion (now part of Janssen), the therapy’s original developer. While…
The specialty pharmaceutical company Neuraxpharm will be responsible for marketing the multiple sclerosis (MS) therapy Briumvi (ublituximab) in regions outside the U.S., Canada, Mexico, and certain Asian countries as part of a new collaboration with TG Therapeutics worth $140 million in upfront payments alone. Neuraxpharm is…
A generic equivalent of oral Gilenya (fingolimod) significantly lowers relapse rates, slows disability progression, and works against new lesions developing in people with relapsing multiple sclerosis (MS), according to a real-world study in Turkey. Feedback from patients also was favorable, with most being satisfied with the generic treatment…
For the first time, multiple sclerosis (MS) therapies have been added to the World Health Organization (WHO)’s Model Lists of Essential Medicines (EML), which names those regarded as meeting the most important needs of healthcare systems worldwide. Glatiramer acetate (sold as Copaxone with generics available), Mavenclad (cladribine)…
Mavenclad (cladribine) is equally as effective as Gilenya (fingolimod) in reducing relapse rates among multiple sclerosis (MS) patients with highly active disease, according to a new real-world comparison. Disability worsening and the development of new lesions also were similar between the two patient groups — but…
Tysabri (natalizumab) is generally safe and effectively lowers disease activity in people with multiple sclerosis (MS), according to a real-world study of patients over a 13-year period in Denmark. “Most patients treated with [Tysabri] are clinically stable with few adverse events,” researchers wrote. In more recent years, doctors…
The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on ongoing trials of evobrutinib, Merck KGaA’s experimental BTK inhibitor for relapsing forms of multiple sclerosis (MS). The decision was based on two cases of patients in Phase 3 clinical trials of evobrutinib who were…
Tascenso ODT, an approved alternative to Gilenya (fingolimod), is now available to multiple sclerosis (MS) patients in the U.S., where it’s being marketed by Cycle Pharmaceuticals. The launch comes about a month after the U.S. Food and Drug Administration approved a 0.5 mg dose of the…
Foralumab, a nasal spray therapy that Tiziana Life Sciences is developing for multiple sclerosis (MS) and other disorders, was well-tolerated in mice for more than three months, according to data from a preclinical study. Tiziana is planning to share that data in a meeting with the U.S. Food…
Consuming alcohol around dosing time could limit the effectiveness of Tecfidera (dimethyl fumarate) for multiple sclerosis patients, a recent study suggests. Results from the study, which involved lab and mouse experiments, showed alcohol inhibits an enzyme in the liver that’s necessary to break down Tecfidera’s main ingredient, dimethyl…
Novartis said it will petition the U.S. Supreme Court to uphold a patent that protects the dosing regimen of Gilenya (fingolimod) that’s approved for relapsing forms of multiple sclerosis (MS). The original patent was not set to expire until the end of 2027, which meant generic versions…