August 24, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Kesimpta, Ocrevus and Chickenpox, Generic Tecfidera, UTIs FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration’s approval of Kesimpta (ofatumumab) this month is a pretty big deal. Kesimpta is a once-a-month injectable disease-modifying therapy. There’s nothing else like it, because Kesimpta targets B-cells in the immune system. Until now, only…
August 20, 2020 News by Marisa Wexler, MS 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…
June 23, 2020 News by InĆŖs Martins, PhD US Court Rules in Favor of Mylan, Generic Version of Tecfidera Generic formulations of dimethyl fumarateĀ ā currently sold as Tecfidera by BiogenĀ ā were given a green light to enter the U.S. market, after a federal courtĀ invalidated a patent protecting Tecfidera from generic competition as aĀ multiple sclerosisĀ (MS) treatment.Ā The ruling by the District Court for the…
June 17, 2020 News by Joana Carvalho, PhD Phase 3 Trial of GA Depot for Relapsing MS Advances With $20M Support Mapi Pharma, supported by an additionalĀ $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),Ā which opened in October 2019,…
October 30, 2019 News by Alice MelĆ£o, MSc First Relapsing MS Patient Enrolled in Phase 3 Trial of Mapi Pharmaās Once-monthly Glatiramer Formulation A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharmaās once-a-month injectable formulation of glatiramer acetate ā named GA Depot ā has started enrolling patients with relapsing multiple sclerosis (MS). The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55…
October 9, 2019 News by Grace Frank US Supreme Court Denies Acorda Appeal on Ampyra Patents, Supporting Generic Versions The U.S. Supreme Court gave a green light to generic versions of Ampyra this week, declining to hearĀ Acorda Therapeutics‘ appeal of a lower court ruling that allowed generics of its treatment for walking or gait problems in multiple sclerosis. That lower court rulingĀ came fromĀ the U.S. District Court…
October 1, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: MRI Signal, Cost-effective DMTs, Age Benefits, Generic Ampyra Often-overlooked MRI Signal May Aid in Early Diagnosis of MS, Other Brain Conditions, Study Suggests A part of an MRI scan that radiologists call a “background signal” is what’s being looked at. It’s usually ignored because the signal doesn’t seem to change even when a patient is…
September 25, 2018 News by Janet Stewart, MSc Dalfampridine ER Tablets, Generic Version of Ampyra, Now Available in US, Mylan Announces Mylan announced its U.S. launch of dalfampridine extended-release (ER) tablets, the authorized generic version of Acorda‘s Ampyra, that work to improve walking abilities in adults with multiple sclerosis (MS). Both versions of this medication come in a 10 mg tablet form. Approved generic medicinesĀ are those that…
August 6, 2018 News by Ana Pena PhD Glatect, Alternative to Copaxone, Added to Public Health Plans of 5 Canadian Provinces Pendopharmās Glatect (glatiramer acetate injection), a lower cost alternative toĀ Tevaās Copaxone, has been added to the public health plans of five Canadian provinces for patients with…
April 11, 2018 News by Alice MelĆ£o, MSc Mapi Pharma, Mylan Partner to Develop Once-monthly Glatiramer Formulation Mylan andĀ Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapyĀ CopaxoneĀ (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…
January 26, 2018 News by Jose Marques Lopes, PhD Brabio, 1st Generic Version of Copaxone for Relapsing MS, Launched in UK Brabio (glatiramer acetate injection), the first generic alternative to CopaxoneĀ for relapsing multiple sclerosis (MS) patients, was recently launched in the U.K. at an equivalent higher dose, its maker,Ā Mylan, announced. Similar to Copaxone Ā ā developed by TevaĀ āĀ Brabio is now available at a 40 mg/ml dose. Both medications are…
December 15, 2017 News by Patricia Silva, PhD Ocrevus’ Use Continues Rising, with RRMS Patients Receiving the Most Attention U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global InsightsĀ reports. Another good sign for Genentech is that, in just three months, neurologists have increased by 50 percent their estimate of the numbers of relapsing-remitting MS patients who could benefit from Ocrevus.
October 5, 2017 News by Patricia Silva, PhD FDA Approves Mylanās Generic Copaxone, Introducing First Generic High-Dose Version The U.S. Food and Drug Administration has approved both lower and higher doses ofĀ Mylanās generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis. It is the first time the agency has authorized a higher-dose generic. Generic versions of the lower dose of 20 mg/mL ā intended for…
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.
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…
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…
October 16, 2014 News by Patricia Silva, PhD U.S. Supreme Court Gives Teva Mixed Reception on Copaxone Patent Case The U.S. Supreme Court deliberated on a request from Teva Pharmaceutical Industries Ltd. to preserve the patent of its multiple sclerosis drug Copaxone from generic competitors until September 2015. Recent reports indicate that the court gave the company a mixed opinion. The hearing occurred this…
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).