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The FDA Has Rejected The New Multiple Sclerosis Drug Lemtrada
Jan 6, 2014The FDA has rejected the new multiple sclerosis drug Lemtrada, saying the drugmaker didn't show the drug's benefits outweigh some serious risks. The agency asked the maker, Genzyme, to test the drug in more clinical trials. The drug was ...
Tags: FDA, Lemtrada, Genzyme, relapsing-remitting MS, rejection
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Danish Biotechnology Firm Genmab Has Unveiled Positive Results From a Phase II Study
Oct 12, 2013Danish biotechnology firm Genmab has unveiled positive results from a Phase II study of its sclerosis drug candidate ofatumumab in relapsing-remitting multiple sclerosis (RRMS). In a randomized study of 232 patients with RRMS, treatment ...
Tags: Genmab, Sclerosis Drug
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A Multiple-sclerosis Drug Was Approved for Sale in Europe on Tuesday
Sep 22, 2013A multiple-sclerosis drug that was at the center of Sanofi SA's SAN.FR +1.12% $20 billion takeover battle for Genzyme Corp. three years ago was approved for sale in Europe on Tuesday, the drug's first regulatory approval world-wide. The ...
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ANMAT Has Cleared Genzyme's Once-Daily
Apr 11, 2013Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has cleared Genzyme's once-daily, oral Aubagio 14mg to treat relapsing forms of multiple sclerosis (MS). The approval of Aubagio was based on safety and ...
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EMA Has Issued a Positive Opinion for Genzyme's Oral Aubagio
Mar 26, 2013The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Genzyme's oral Aubagio (teriflunomide) for relapsing-remitting multiple sclerosis (MS). Aubagio did not ...
