Alvogen recently announced the launch of Remurel (glatiramer acetate) in Central and Eastern Europe, making it the first generic equivalent of Copaxone to be clinically validated for the treatment of relapsing forms of multiple sclerosis (RRMS) in Europe. European health authorities determined that Remurel 20 mg was the therapeutic equivalent…
Copaxone
In addition to a new study sponsored by Genentech to test the experimental MS therapy Ocrevus (ocrelizumab) in RMS patients who have had a sub-optimal response to previous disease modifying therapies, the company is also currently recruiting patients with relapsing multiple sclerosis to understand the therapy’s mechanism of action and B-cell biology…
Disease Modifying Drugs Seen to Help Protect MS Patients with Benign Status from Greater Disability
Women with multiple sclerosis (MS) and people diagnosed with the disease at a younger age are more likely to have a benign course of MS, remaining fully functional for decades after disease onset, according to researchers at the School of Medicine and Biomedical Sciences in New York. Disease modifying drugs were also found…
The Russian Ministry of Health recently granted Marketing Authorization (ЛП-003567) to R-Pharm JSC for the development of “Glatirat” (Glatiramer acetate), a drug intended for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome. According to a press release, the registration of “Glatirat” was based…
Researchers at the University of Heidelberg, Germany, recently showed that peripheral blood cells loaded with a drug that resembles the myelin protein are able to inhibit harmful immune responses and prevent relapses in a mouse model of relapsing-remitting multiple sclerosis (MS). The findings were described in the study “…
Teva Pharmaceutical Industries, Ltd., announced that new data on four of its products, including an approved and a potential treatment for multiple sclerosis, will be presented at the 68th Annual Meeting of the American Academy of Neurology (AAN), running through April 21 in Vancouver, Canada. The data, to be…
Synthetic Biologics, Inc., a clinical stage company focused on the development of therapeutics to protect the microbiome and to target disease-causing pathogens, recently announced disappointing results from an independent third-party analysis of a Phase 2 clinical trial evaluating Trimesta as a treatment for relapsing-remitting multiple sclerosis (RRMS) in women.
Results from a small pilot study indicated that high-dose vitamin D supplementation is safe and tolerable in patients with multiple sclerosis (MS), and that it can reduce the presence of autoimmunity-causing immune T cells. Patients are now being recruited for a larger clinical trial. The study, entitled “Safety and immunologic…
Takeda Pharmaceutical, a pharmaceutical company based in Osaka, Japan, recently announced that a widely approved drug treatment for the prevention of relapses in multiple sclerosis (MS) is now available in Japan as well. Copaxone, (glatiramer acetate; 20 mg daily subcutaneous injection), developed by Teva Pharmaceuticals, is an immunomodulatory drug designed to act as…
Synthetic Biologics, which specializes in the development of therapies for pathogen-specific diseases, recently announced the publication of new and positive data on results from a Phase 2 clinical trial evaluating the company’s product Trimesta™ as a treatment for relapsing-remitting multiple sclerosis (RRMS) in women. Professor Rhonda Voskuhl, director of the Multiple Sclerosis Program…
In a recent study entitled “Equivalent Gene Expression Profiles between Glatopa™ and Copaxone®,” authors determined potential differences in treatment responses by investigating the gene expression profile of two approved treatments for relapsing forms of multiple sclerosis – Copaxone and Glatopa. Both of these MS therapies are glatiramer…
Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day, recently announced the approval of a Marketing Authorization license (MA) by the Russian Ministry of Health for three-times-per-week COPAXONE®(glatiramer acetate injection) 40 mg/mL, a new dose of COPAXONE®,…
The Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone (GATE) seems to be the first phase 3 clinical trial to test a generic disease-modifying medication for multiple sclerosis (MS) treatment. The data showed that glatiramer acetate, the generic drug, was equivalent to the trademark drug Copaxone for the…
A Satellite Symposia entitled “Discovering a new world in MS” presented by Teva Neuroscience was held yesterday, October 8 at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) currently taking place in Barcelona, Spain, October 7 – 10, 2015. Dr. Omar Khan from the…
The world’s largest generic medicines manufacturer, Teva Pharmaceutical, is at the 31st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress currently ongoing in Barcelona, from October 7-10, 2015. Teva will be presenting the latest findings on its relapsing multiple sclerosis (MS) therapy COPAXONE® (glatiramer acetate injection), and product candidate for…
Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions, recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the once per day 20 mg injection of COPAXONE® as prophylaxis for relapses in multiple sclerosis (MS). Glatiramer acetate, the active…
According to a press release from Mylan N.V., the U.S. Patent and Trademark Office (PTO) has issued an inter partes review (IPR) proceeding on all claims against a third Copaxone patent for the 40 mg/mL (U.S. Patent No. 8,969,302) formulation by Yeda Research & Development Co., Ltd.
Netherlands-based international pharmaceutical company Synthon, best known for developing complex generic therapeutics, has officially entered into an agreement with pharmaceutical giant Pfizer, Inc., effectively transferring the exclusive rights in the US to glatiramer acetate to Pfizer. Glatiramer acetate is an experimental generic formulation of Copaxone, which is indicated as a…
Reality TV star Jack Osbourne has partnered with Teva Pharmaceutical Industries Ltd. to launch a new website as part of a three-year campaign called You Don’t Know Jack About MS. The site can be viewed here: www.youdontknowjackaboutms.com. The campaign is meant to raise awareness about…
The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version of Copaxone (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (MS). The administration has granted Sandoz marketing authorization for glatiramer acetate in 20 mg/1 ml…
Teva Pharmaceutical Industries Ltd. recently made a major announcement on the U.S. Supreme Court‘s ruling on the matter of “Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Court’s judgment of invalidity…
Takeda Pharmaceutical Company Limited (Takeda) announced late last month its New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the multiple sclerosis relapse prevention drug glatiramer acetate (active ingredient) — which is sold in some markets under the trade name Copaxone. Developed by Israel’s Teva Pharmaceutical Industries…
Mapi Pharma Ltd., a development stage pharmaceutical company specializing in the development of high-barrier to entry and high-added value generic drugs, announced it has treated the first patient in the Phase IIa study of GA Depot for relapsing-remitting multiple sclerosis (RRMS). Lead investigator Professor Ariel Miller, M.D., Ph.D., Head of the Multiple Sclerosis & Brain…
Israel-based biopharmaceutical company Teva Pharmaceutical Industries Ltd. announced last week that its thrice-weekly COPAXONE® (glatiramer acetate) 40mg/ml treatment for relapsing-remitting multiple sclerosis (RRMS) has received positive results in a decentralized procedure. The favorable outcome proceeds a Positive Assessment Report from the United Kingdom, the Reference Member…
Teva Pharmaceutical Industries Ltd., the company behind multiple sclerosis drug COPAXONE® (glatiramer acetate injection), has been pursuing the US Food and Drug Administration‘s decision against approving a generic version of the drug, by Mylan, Inc. Teva’s petition has been turned down several times,…
Teva Pharmaceutical Industries Ltd., the company that developed the injectable multiple sclerosis treatment Copaxone (Glatiramer acetate), has announced their pursuit of regulatory approval in Japan. This development comes a year after signing an agreement with Takeda Pharmaceutical Co. Ltd. According to a…
The U.S. Food and Drug Administration (FDA) accepted the abbreviated new drug application (ANDA) for filing of a Glatiramer Acetate Injection for the treatment of patients with relapsing forms of multiple sclerosis (MS).
Synthetic Biologics, Inc., a biotechnology company developing novel drug candidates targeting specific pathogens that cause serious infections and diseases, announced that its latest data on Trimesta™, regarding cognitive and disability measures in women suffering from multiple sclerosis (MS), will be presented at the 2014 Joint Americas and European Committees…
The risk of developing lipoatrophy for multiple sclerosis (MS) patients administrated with glatiramer acetate is greater than 60 percent, according to a study developed at the Riverside Medical Clinic that reviewed 73 MS patients. It was already known that the drug could cause the condition, however the rate is higher…
Positive study results from a preliminary phase II clinical trial for a new potential therapeutic intervention for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) were recently released at the American Academy of Neurology’s Annual Meeting in Philadelphia by Dr. Rhonda Voskuhl, M.D., from the University of California, Los Angeles.