May 27, 2016 News by Patricia Silva, PhD R-Pharm Group To Launch Glatirat, an Analogue of Copaxone for MS Treatment The Russian Ministry of HealthĀ recently granted Marketing Authorization (ŠŠ-003567) to R-Pharm JSC for the development of Ā āGlatiratā (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 āGlatiratā was based…
May 23, 2016 News by InĆŖs Martins, PhD Relapses Prevented in Multiple Sclerosis Mouse Model Researchers at theĀ 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 “…
April 15, 2016 News by Patricia Silva, PhD Teva to Present Pipeline Data on MS Treatments at Ongoing AAN Annual Meeting 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 atĀ the 68th Annual Meeting of the American Academy of Neurology (AAN), running through April 21 in Vancouver, Canada. The data, to be…
February 8, 2016 News by Margarida Azevedo, MSc Experimental RRMS Therapy, Trimesta, Fails to Demonstrate Efficacy in Review of Clinical Trial 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.
January 4, 2016 News by Margarida Azevedo, MSc Pilot MS Study Suggests High-Dose Vitamin D Supplements Are Safe and Beneficial 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 presenceĀ of autoimmunity-causing immune T cells. Patients are now being recruited for a larger clinical trial. The study, entitled āSafety and immunologic…
December 7, 2015 News by Patricia Silva, PhD Relapsing Multiple Sclerosis Treatment Now Available in Japan Takeda Pharmaceutical, a pharmaceutical company based in Osaka, Japan, recently announcedĀ that a widely approved drug treatment forĀ the prevention of relapses in multiple sclerosis (MS)Ā is nowĀ available in Japan as well. Copaxone,Ā (glatiramer acetate; 20 mg daily subcutaneous injection), developed by Teva Pharmaceuticals, is an immunomodulatory drug designed toĀ act as…
December 2, 2015 News by Patricia Silva, PhD Experimental Relapsing-Remitting MS Drug Treatment Advancing Synthetic Biologics, which specializes in the development of therapies forĀ pathogen-specific diseases, recently announced theĀ publication of new and positive data on results from a Phase 2 clinical trial evaluating the companyās product Trimestaā¢ as a treatment for relapsing-remitting multiple sclerosis (RRMS) in women. Professor Rhonda Voskuhl, director of theĀ Multiple Sclerosis Program…
October 20, 2015 News by Patricia Inacio, PhD Generic Form of Glatiramer Acetate Has Equivalent Gene Expression Profile as Teva’s Copaxone In a recent study entitled āEquivalent Gene Expression Profiles between Glatopaā¢ and CopaxoneĀ®,ā authors determined potential differences in treatment responses by investigating the gene expression profile of two approved treatments for relapsing forms of multiple sclerosis ā Copaxone and Glatopa. Both of these MS therapies are glatiramer…
October 19, 2015 News by Patricia Silva, PhD Teva Pharmaceutical Industries’ COPAXONE 40 mg/mL Three-times-a-week Approved in Russia for Relapsing-Remitting Multiple Sclerosis 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 COPAXONEĀ®(glatiramer acetate injection) 40 mg/mL, a new dose of COPAXONEĀ®,…
October 16, 2015 News by Patricia Silva, PhD GATE Trial Supports Generic Glatiramer Acetate as an Alternative Therapy for Relapsing-Remitting Multiple Sclerosis The Glatiramer Acetate Clinical Trial to Assess Equivalence With CopaxoneĀ (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…
October 9, 2015 News by Patricia Silva, PhD New 3-Times-Per-Week Regimen For Teva’s Copaxone Safe, Effective & Increases Patient Compliance #ECTRIMS2015 A Satellite Symposia entitled āDiscovering a new world in MSā presentedĀ by Teva Neuroscience was held yesterday, October 8 at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)Ā currently taking place in Barcelona, Spain, October 7 ā 10, 2015. Dr. Omar Khan from the…
October 7, 2015 News by Patricia Silva, PhD Teva Pharmaceuticals to Present New Data on Multiple Sclerosis Drugs Copaxone and Laquinimod at ECTRIMS 2015 The world’sĀ largest generic medicines manufacturer,Ā Teva Pharmaceutical, is at theĀ 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 COPAXONEĀ®Ā (glatiramer acetate injection), and product candidate for…
September 30, 2015 News by Patricia Silva, PhD Teva’s COPAXONE Approved in Japan for the Prevention of Relapse Remitting Multiple Sclerosis 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 COPAXONEĀ®Ā as prophylaxis for relapses in multiple sclerosis (MS). Glatiramer acetate, the active…
September 4, 2015 News by Marta Silva Mylan Confirms Continued Patent Proceedings Concerning MS Therapy Copaxone According toĀ a press release from Mylan N.V., the U.S. Patent and Trademark Office (PTO) has issuedĀ 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) formulationĀ by Yeda Research & Development Co., Ltd.
August 4, 2015 News by Patricia Silva, PhD Pfizer Acquires Exclusive Commercialization Rights to Generic Copaxone for Relapsing Remitting Multiple Sclerosis 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…
June 3, 2015 News by Patricia Silva, PhD Jack Osbourne and Teva Launch New Educational Multiple Sclerosis Website Reality TV star Jack Osbourne has partnered with Teva Pharmaceutical Industries Ltd. to launch aĀ new website as part ofĀ aĀ 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…
April 17, 2015 News by Patricia Silva, PhD First Generic Version of Copaxone Approved by FDA to Treat Multiple Sclerosis The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version ofĀ CopaxoneĀ (glatiramer acetate injection) for the treatment ofĀ relapsing forms of multiple sclerosis (MS). The administration has grantedĀ Sandoz marketing authorization forĀ glatiramer acetate in 20 mg/1 ml…
January 26, 2015 News by Patricia Silva, PhD US Supreme Court Rules on Teva Pharma’s Copaxone Patent Case 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 Courtās judgment of invalidity…
January 9, 2015 News by Charles Moore Takeda Submits Application For New Multiple Sclerosis Relapse Prevention Drug Glatiramer Acetate in Japan 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 acetateĀ (active ingredient)Ā — which is sold in some marketsĀ under the trade name Copaxone. Developed by Israel’s Teva Pharmaceutical Industries…
December 19, 2014 News by Patricia Silva, PhD Mapi Pharma Treats First RRMS Patient with Once-A-Month GA Depot Mapi Pharma Ltd.,Ā a development stage pharmaceutical company specializingĀ in the development of high-barrier to entry and high-added value generic drugs, announced it has treated the first patient in theĀ Phase IIa study of GA Depot forĀ relapsing-remitting multiple sclerosis (RRMS). Lead investigatorĀ ProfessorĀ Ariel Miller, M.D., Ph.D., Head of the Multiple Sclerosis & Brain…
December 9, 2014 News by Patricia Silva, PhD 3 Times a Week Dose Copaxone for Relapsing MS Receives Positive Outcome in Europe Israel-based biopharmaceutical companyĀ Teva Pharmaceutical Industries Ltd. announced last week that its thrice-weekly COPAXONEĀ® (glatiramer acetate) 40mg/ml treatment for relapsing-remitting multiple sclerosis (RRMS) has received positive results in a decentralized procedure. The favorable outcome proceeds aĀ Positive Assessment Report from the United Kingdom, the Reference Member…
December 1, 2014 News by Patricia Silva, PhD FDA Delays Ruling on Teva Petition Against Generic Copaxone for MS Teva Pharmaceutical Industries Ltd., the company behind multiple sclerosis drugĀ COPAXONEĀ® (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.Ā Teva’s petition has been turned down several times,…
November 17, 2014 News by Patricia Silva, PhD Teva Pursues Regulatory Approval in Japan for MS Drug Copaxone Teva Pharmaceutical Industries Ltd., the company that developed the injectable multiple sclerosis treatment Copaxone (Glatiramer acetate), Ā 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…
September 2, 2014 News by Patricia Silva, PhD Mylan’s Generic Copaxone Injection ANDA Approved for Filling by the FDA The U.S. Food and Drug Administration (FDA) acceptedĀ theĀ abbreviated new drug application (ANDA)Ā forĀ filingĀ of aĀ Glatiramer Acetate InjectionĀ for the treatment of patients with relapsing forms of multiple sclerosis (MS).
August 1, 2014 News by admin Data From Multiple Sclerosis Study of Trimesta For Disability, Cognitive Improvements in Women To Be Presented at ACTRIMS-ECTRIMS 2014 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 Trimestaā¢, regarding cognitive and disability measures in women suffering from multiple sclerosis (MS), will be presented at the 2014 Joint Americas and European Committees…
June 18, 2014 News by Patricia Silva, PhD Lipoatrophy Occurrence for MS Patients Higher than Originally Thought 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 theĀ Riverside Medical Clinic that reviewed 73 MS patients. It was already known that the drug could cause the condition, however the rate is higher…
May 20, 2014 by Patricia Silva, PhD Combination Therapy For Multiple Sclerosis Offers Promising Results In Recent Study Positive study results from a preliminary phase II clinical trialĀ for a new potential therapeutic intervention for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) were recentlyĀ released at the American Academy of Neurology’s Annual Meeting in Philadelphia by Dr.Ā Rhonda Voskuhl, M.D., from the University of California, Los Angeles.
May 6, 2014 by admin Combined Multiple Sclerosis Therapy Using Copaxone Relieves RRMS Symptoms In Study Although the biological activity by which Copaxone (glatiramer) exerts its effects iĀ multiple sclerosis (MS) patients is not fully understood, it is believed it can block the induction of autoimmune encephalomyelitis as observed in recent experiments with mice.Ā Research in animals and in vitro systems suggest that glatiramer acetate-specific suppressor…