The 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
Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of ...
Tags: Genzyme, Biologics License Application, Lemtrada, multiple sclerosis
The French maker of a drug used to treat multiple sclerosis is "extremely disappointed" it was rejected for U.S. sale, a corporate official said. David Meeker, president of Sanofi's Genzyme subsidiary, maker of the drug Lemtrada, said he ...
Genzyme, a Sanofi company, has obtained an approval from Health Canada for its Lemtrada (alemtuzumab) for the treatment of relapsing remitting multiple sclerosis (RRMS). Health Canada has approved Lemtrada for the management of adult ...
Alnylam Pharmaceuticals, a RNAi therapeutics company, announced that the US Food and Drug Administration (FDA) has granted fast track designation to patisiran (ALN-TTR02) for the treatment of transthyretin (TTR)-familial amyloid ...
Tags: Alnylam, Fast Track Designation
Fidelity Biosciences, a subsidiary of Fidelity Investments, and US-based Regenx Biosciences have announced the formation of Dimension Therapeutics, a gene therapy company focused on developing novel treatments for rare diseases. Dimension ...
Tags: Biosciences, Health, Medicine
A 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 ...
Argentina'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 ...
The 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 ...
Genzyme and Isis have announced the FDA approval of Kynamro (mipomersen sodium) injection indicated for homozygous familial hypercholesterolemia (HoFH). The regulatory agency approved Kynamro 200mg subcutaneous injection per week as an ...
The US FDA has accepted Genzyme Lemtrada (alemtuzumab) biologics license application (sBLA) for review for relapsing multiple sclerosis (RMS). Genzyme also reported encouraging early US launch indicators for Aubagio (teriflunomide) such ...
Tags: FDA, biologics license application, relapsing multiple sclerosis
Sanofi company, Genzyme has received approval of a product label expansion from the European Commission for the use of Thyrogen (thyrotropin alfa) with a broad irradiation dose range for postoperative thyroid remnant ablation. The ...
Tags: label, postoperative thyroid remnant ablation, revised labeling
The European Commission has cleared the expanded use of Genzyme's Thyrogen(thyrotropin alfa)cancer therapy for patients with postoperative thyroid remnant ablation. The new approval allows administration of a reduced dose of radioiodine ...
Tags: European Commission, Genzyme, Thyrogen, cancer therapy
Genzyme, a Sanofi company, has submitted a new drug application to the FDA seeking approval for KYNAMRO for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The submission is based on trial in which ...
Tags: KYNAMRO, homozygous familial hypercholesterolemia, HoFH
Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS). In collaboration with ...
Tags: sBLA, relapsing multiple sclerosis, RMS