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European Commission grants marketing authorisation for Vumerity® EuropeanPharmaceuticalReview
November 18, 2021
Biogen has announced that the European Commission (EC) has granted marketing authorisation for Vumerity® (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).
Dr Reddy’s launches dimethyl fumarate DR capsules in US expresspharma
September 28, 2020
Dr Reddy’s Laboratories announced the launch of dimethyl fumarate delayed-release capsules, a therapeutic equivalent generic version of Tecfidera (dimethyl fumarate) delayed-release capsules, approved by the US Food and Drug Administration (USFDA).
Mylan announces launch of generic version of Biogen’s Tecfidera expresspharma
August 20, 2020
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS).
Mylan Wins District Court Decision against Biogen's Tecfidera Patent americanpharmaceuticalreview
June 30, 2020
Mylan announced the U.S. District Court for the Northern District of West Virginia invalidated Biogen's Tecfidera® patent, U.S. Patent No. 8,399,514, for lack of written description.
Biogen faces multibillion-dollar Tecfidera loss if Mylan wins latest patent threat fiercepharma
February 24, 2019
Cash cow Tecfidera has been pumping out blockbuster sales as Biogen plows ahead with pricey Alzheimer's trials and scouts for new pipeline assets. But what if those sales took a big hit early next year, instead of eight years later?
Shilpa Medicare gets tentative US FDA nod for multiple sclerosis drug expressbpd
November 17, 2018
The company’s abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (US FDA), Shilpa Medicare said
Shilpa Medicare gets tentative US FDA nod for multiple sclerosis drug expressbpd
November 17, 2018
The company’s abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (US FDA), Shilpa Medicare said
Forward Pharma loses Tecfidera patent appeal against Biogen pharmatimes
November 01, 2018
Forward Pharma has lost its appeal on a US Patent Trial and Appeal Board decision that validated patents for Biogen's blockbuster MS drug Tecfidera (dimethyl fumarate).
Study Shows Biogen’s MS drug Tecfidera could make cancer-killing viruses more potent fiercebiotech
January 26, 2018
The Cancer-killing“oncolytic” viruses, which was derived from herpes, made their way into oncology practices in 2015 with Amgen’s melanoma drug Imlygic being approved.