Genzyme, a Sanofi company announced today that they will resubmit its supplemental Biologics License Application (sBLA) for approval of Lemtrada (alemtuzumab) for relapsing forms of multiple sclerosis, according to a press release issued by Genzyme. Following discussions with the Food and Drug Administration (FDA), Genzyme intends to submit the application, addressing issues previously noted by the FDA in its Complete Response Letter.
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Multiple Sclerosis Association of America’s Nationwide Search Uncovers Inspiring Stories of People Living with MS Who Swim for Better Health
In honor of Multiple Sclerosis (MS) Awareness Month, the Multiple Sclerosis Association of America (MSAA), through a collaborative partnership with Genzyme, a Sanofi company, is proud to announce the stories from three individuals in the MS community who describe how swimming has helped manage their MS symptoms and improve their overall well-being. Today, MSAA is unveiling their compelling stories captured on video at www.SwimForMS.org, along with new how-to resources about water-based exercise to help improve the lives of individuals living with MS.
Read News ArticleMSAA Partners with Wearable Hope to Raise Funds and Awareness for MS
The Multiple Sclerosis Association of America (MSAA) has been chosen as Wearable Hope’s partner organization of the week! Starting March 4, 2014, you can shop for MSAA t-shirts at www.wearablehope.com and choose from one of two custom designed shirts.
Read News ArticleMarch is MS Awareness Month
The Multiple Sclerosis Association of America (MSAA) recognizes March as MS Awareness Month. MSAA urges everyone to help raise awareness of multiple sclerosis throughout your community and help improve the lives today for people with MS and their families.
Read News ArticleThe Multiple Sclerosis Association of America Publishes 2014 MS Research Update
The Multiple Sclerosis Association of America (MSAA) is pleased to offer the latest MS Research Update, available as both a printed and online publication. This vital resource provides a comprehensive overview of research findings on the ten FDA-approved disease-modifying therapies for relapsing forms of multiple sclerosis (MS), as well as the latest study results on many experimental treatments currently under investigation. Directions for future research are also presented.
Read News ArticleMS Coalition Submits Letter to FDA Regarding Lemtrada Denial
The Multiple Sclerosis Coalition (MSC) is a collaborative network of independent MS organizations whose mission is to increase opportunities for cooperation and provide greater opportunity to leverage the effective use of resources for the benefit of the MS community. Members of this organization have collectively sent a letter to the United States Food and Drug Administration (FDA), asking for clarification and reconsideration of various issues involved in the FDA’s recent denial of Lemtrada™ (alemtuzumab, formerly Campath).
Read News ArticleNew Copaxone Dosing Approved for Fewer Injections
On January 28, 2014, Teva Pharmaceutical Industries Ltd. announced that the new, three-times-per-week dosing of Copaxone® (glatiramer acetate), at the more concentrated dose of 40 mg, has been approved by the FDA. This new formulation enables individuals who take Copaxone to reduce their number of subcutaneous injections by 60 percent – from seven times per week to three times – once they are prescribed the new dosing regimen by their doctor. Teva states that in addition to the newly approved dose, daily Copaxone at the traditional 20-mg dose will continue to be available.
Read News ArticleLemtrada Denied FDA Approval; More Studies Needed
Lemtrada™ (alemtuzumab, formerly Campath) did not receive approval from the United States Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis (MS). Genzyme, a Sanofi company, announced today that it had received a Complete Response Letter from the FDA, informing them that the application for their drug is “not ready for approval.”
Read News ArticleThe Multiple Sclerosis Association of America Announces Swim for MS – Why I Swim Campaign
The Multiple Sclerosis Association of America (MSAA) announces a national call for entries for the Swim for MS – Why I Swim campaign, through a collaborative sponsorship with Genzyme, a Sanofi company. Individuals with multiple sclerosis (MS) who currently swim or participate in water-based exercise programs are encouraged to visit SwimForMS.org and share their personal story about how water activities have impacted their lives.
Read News ArticleFDA Committee Recommends Lemtrada for Approval
On November 13, 2013, the United States Food and Drug Administration (FDA) held a meeting to discuss Lemtrada® (alemtuzumab, also known as Campath), a new treatment that has been submitted for approval to treat relapsing forms of multiple sclerosis (MS). Despite concerns over the drug’s safety as well as study design, the FDA’s committee voted to recommend the drug for approval.
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