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ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has approved LemtradaTM (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. [More]
Genzyme: FDA accepts resubmission of Lemtrada sBLA

Genzyme: FDA accepts resubmission of Lemtrada sBLA

Genzyme, a Sanofi company, announced today 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 LemtradaTM (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. [More]
Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate. [More]
Tgen professor to receive 2014 Hope Funds Award for developing numerous cancer treatments

Tgen professor to receive 2014 Hope Funds Award for developing numerous cancer treatments

Dr. Daniel D. Von Hoff, who has been instrumental in developing numerous new cancer treatments, is among this year's recipients of the Award of Excellence from the Hope Funds for Cancer Research. [More]
Brazil's ANVISA approves Genzyme's Lemtrada for multiple sclerosis treatment

Brazil's ANVISA approves Genzyme's Lemtrada for multiple sclerosis treatment

Genzyme, a Sanofi company, announced today that Brazil's national health surveillance agency, ANVISA, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations. [More]
New study reveals way to combat drug-resistant tumors

New study reveals way to combat drug-resistant tumors

Cancer drugs that recruit antibodies from the body's own immune system to help kill tumors have shown much promise in treating several types of cancer. However, after initial success, the tumors often return. [More]
Viewpoints: Is overhaul really a 'war' on the young?; war on poverty requires spending; maternity leave in America

Viewpoints: Is overhaul really a 'war' on the young?; war on poverty requires spending; maternity leave in America

A long-shot lawsuit that could have damaged the effectiveness of health care reform got a well-deserved brushoff from a federal district judge on Wednesday. [More]
Genzyme gets FDA Complete Response Letter for Lemtrada sBLA

Genzyme gets FDA Complete Response Letter for Lemtrada sBLA

Genzyme, a Sanofi company, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. [More]
Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

Genzyme, a Sanofi company, announced today that the Australian Therapeutic Goods Administration has approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses. [More]
Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

Genzyme, a Sanofi company, announced today that Health Canada has approved Lemtrada (alemtuzumab) for the management of adult patients with relapsing remitting multiple sclerosis, with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies. [More]
Genzyme's MS Drug Lemtrada Receives EU Authorization

Genzyme's MS Drug Lemtrada Receives EU Authorization

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EMA's CHMP issues positive opinion for approval of Genzyme's LEMTRADA in Europe

EMA's CHMP issues positive opinion for approval of Genzyme's LEMTRADA in Europe

Genzyme, a Sanofi company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for approval of LEMTRADA (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features. [More]
Genmab, ADC Therapeutics agree to develop new antibody-drug conjugate product

Genmab, ADC Therapeutics agree to develop new antibody-drug conjugate product

Genmab A/S and ADC Therapeutics Sarl, announced today an agreement to develop a new antibody-drug conjugate product combining Genmab's HuMax-TAC antibody and ADC Therapeutics' PBD-based warhead and linker technology. [More]
FDA accepts Genzyme’s LEMTRADA sBLA for review

FDA accepts Genzyme’s LEMTRADA sBLA for review

Genzyme, a Sanofi Company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). [More]
Lymphocyte clue to multiple sclerosis drug response

Lymphocyte clue to multiple sclerosis drug response

Patients with rapid recovery of CD4-positive T cells after alemtuzumab treatment for multiple sclerosis are at risk for disease progression or relapse, research suggests. [More]
Doctors should use different therapies when treating older and younger patients with CLL

Doctors should use different therapies when treating older and younger patients with CLL

Doctors should use different therapies when treating older and younger patients with chronic lymphocytic leukemia, according to a new study led by researchers at the Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James). [More]
Caution over monoclonal antibody treatment for MS

Caution over monoclonal antibody treatment for MS

Alemtuzumab, an anti-CD52 monoclonal antibody, provides a more effective treatment for individuals with relapsing‑remitting multiple sclerosis than the immunomodulating drug interferon beta 1a, but has significant side effects, show findings from a phase III trial. [More]
Multiple sclerosis disease activity reduced by leukaemia drug, even when first-line treatment has failed

Multiple sclerosis disease activity reduced by leukaemia drug, even when first-line treatment has failed

A drug which was originally developed to treat leukaemia and other cancers of the immune system offers substantial improvements over existing treatments in reducing relapse rates for people with multiple sclerosis (MS), even when they have not responded well to first-line treatment, according to the results of two phase 3 trials published Online First in The Lancet. [More]
New data from Genzyme's AUBAGIO and LEMTRADA clinical trials to be presented at ECTRIMS

New data from Genzyme's AUBAGIO and LEMTRADA clinical trials to be presented at ECTRIMS

Genzyme, a Sanofi company, announced today new data from Genzyme's clinical development programs for AUBAGIO (teriflunomide) and LEMTRADATM (alemtuzumab) will be presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France, October 10-13. [More]
Genzyme receives Refuse to File letter from FDA for LEMTRADA

Genzyme receives Refuse to File letter from FDA for LEMTRADA

Genzyme, a Sanofi company, announced it has received a Refuse to File letter from the U.S. Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of LEMTRADA (alemtuzumab) as a treatment for relapsing multiple sclerosis. [More]