Biogen

Tecfidera Approved in China to Treat Relapsing MS

Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people withĀ relapsing multiple sclerosis (MS) ā€” clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decisionĀ came through a priority review of clinical trial data for Tecfidera,…

Under-the-skin Injection of Tysabri Approved in Europe

The European Commission (EC) has approved a new method to administer Tysabri (natalizumab) as a treatment for people with relapsing-remittingĀ multiple sclerosis (RRMS). This new delivery route involves a subcutaneous injection in which Tysabri is injected under the skin. Compared with the previously approved intravenous (into the bloodstream) formulation,…

FDA Approves Plegridy as Intramuscular Injection for Relapsing MS

The U.S. Food and Drug Administration (FDA) has approved an intramuscular injectionĀ formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing forms of multiple sclerosis (MS). This formulation, for injection directly into muscle, is what is typically used to deliver the flu shot. According to Biogen, Plegridy’s…

New Study Will Assess Tysabri Effects on MS Cognitive Fatigue

Researchers from the Kessler Foundation will launch a new study investigating the effects of Tysabri (natalizumab) on cognitive fatigue ā€” the type of fatigue that happens after strong mental concentration, such as in problem-solving ā€” in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue, which is very…

Plegridy as Intramuscular Injection for RRMS Approved in Europe

The European Commission (EC) has approved a new, intramuscular formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing-remitting multiple sclerosis (RRMS). This new mode of administration ā€” in which Plegridy is directly injected into the muscle, rather than under the skin (subcutaneously) ā€” does…

Tysabri Superior to Gilenya at Easing Activity in RRMS, Study Reports

Treatment with Tysabri (natalizumab) was more effective thanĀ Gilenya (fingolimod) in helping people with relapsingā€“remitting multiple sclerosis (RRMS) achieve no evidence of disease activity, a head-to-head study suggested. The study, “BEST-MS: A prospective head-to-head comparative study of natalizumab and fingolimod in active relapsing MS,” was…

Biogen Discontinues Development of Opicinumab for MS

BiogenĀ is discontinuing the clinical development of opicinumab,Ā its experimental treatment candidate forĀ multiple sclerosisĀ (MS), based on data from the Phase 2 AFFINITY clinical trial. The announcement, amid a third-quarter report, indicated that the study failed to meet both its main and secondary goals, without further details. The trial,…

Restarting Rituxan: One Down, and a Lifetime to Go

Last week, I again started my twice-annual infusion of Rituxan (rituximab). After 384 days without my disease-modifying therapy, my team decided I could no longer wait. In its absence, my symptomology had worsened. Halting progression trumped a pandemic, and with personal protective equipment in place, I begin…

Mylan Launching Tecfidera Generic in US

Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS). The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid ā€”…