Teva Pharmaceutical Industries Ltd., the company that developed the injectable multiple sclerosis treatment Copaxone (Glatiramer acetate), Â 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…
Drug approval
Now more than ever, groundbreaking, new therapies for chronic diseases and infections come with high price tags. Earlier in the year, Gilead Sciences’ drug Sovaldi for Hepatitis C, as well as Vertex’s Kalydeco for Cystic Fibrosis, both raised eyebrows over their cost. Now, a new MS therapy is doing the…
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).
Biogen Idec, a biotechnology company focused on developing innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders, has announced that the U.S. Food and Drug Administration (FDA) has approved PLEGRIDYTMÂ (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis…
The European Commission granted marketing authorization for the use of Plegridy, a drug developed by Biogen Idec as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). The approval comes at a time when…
The U.S. Food and Drug Administration (FDA) recently notified Concert Pharmaceuticals that the company had fulfilled all necessary preclinical toxicological tests for the oral therapy CTP-354 for the treatment of multiple sclerosis, spinal cord injury, and spasticity. The authorization to administer repeated doses of the compound, in excess of 6 mg per day,…
The UK’s National Institute for Health and Care Excellence (NICE) gave a positive final appraisal determination to the use of the Biogen Idec‘s drug Tecfidera (dimethyl fumarate) in adults for the treatment of relapsing-remitting multiple sclerosis (RRMS), having turned back on their preliminary negative recommendation. The oral…
The Scottish Medicines Consortium (SMC)  announced the approval of the drug Lemtrada, produced by Genzyme, for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) and active disease defined by clinical or imaging features, within the national health system (NHS) in Scotland. Lemtrada…
Lemtrada, a drug produced by Genzyme for the treatment of adult patients suffering from relapsing remitting multiple sclerosis (RRMS) with active disease, was approved by Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT). “We are pleased by the continued global support for Lemtrada,” said Genzyme…
Cambridge, Mass. Based Genzyme, a Sanofi subsidiary, announced May 30 that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of its proprietary drug Lemtrada (alemtuzumab) for treatment of relapsing forms of multiple sclerosis (MS).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recently offered a positive opinion for the marketing authorization of Biogen Idec’s Plegridy therapy, a pegylated interferon administered subcutaneously for adults with relapsing-remitting multiple sclerosis (RRMS). The positive opinion will now be sent to the European Commission, which grants…
Two pharmaceutical companies, Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech, have just confirmed reports that the Committee for Medicinal Products for Human Use (CHMP) is not recommending NERVENTRA (laquinimod) for use in treating relapsing-remitting multiple sclerosis (RRMS) within the European Union (EU), according to a recent press release. Despite CHMP’s disapproval of TEVA…