The U.S. Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. The drug has already been approved by the European Medicines Agency for use in the European Union and in Canada and Australia.
Genzyme, a Sanofi company, today announced the establishment of a research collaboration with...
Genzyme, a Sanofi company announced that the FDA approved a supplement to expand the indication...
Genzyme Announces Multi-Year Multiple Sclerosis Research Collaboration with Leading Academic Medical CenterApril 30, 2014 11:40 am | News | Comments
Genzyme, a Sanofi company has announced the formation of a research collaboration with Cleveland...
Genzyme has announced that Mexico’s national regulatory authority, COFEPRIS, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.
Genzyme, a Sanofi company , and Alnylam Pharmaceuticals, Inc. announced today that they have significantly expanded their strategic agreement to develop and commercialize treatments for rare genetic diseases. Genzyme will have significant rights to Alnylam’s portfolio of clinical and pre-clinical stage drug candidates.
The U.S. Food and Drug Administration has notified drug maker Genzyme that its treatment for multiple sclerosis is not ready for approval for the American market.
Genzyme, a Sanofi company, is investing $80 million to build a new downstream processing facility for Fabrazyme® (agalsidase beta). The new plant, which will be located adjacent to the new Fabrazyme cell culture manufacturing site in Framingham, Massachusetts, will significantly expand purification capacity to support anticipated growth in global demand over the coming years.
The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
Genzyme, a Sanofi company, announced today Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO® 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS).
Drug developer Isis Pharmaceuticals Inc. and partner Genzyme announced Tuesday that the U.S. Food and Drug Administration has approved their new drug application for Kynamro, clearing the way for Isis' first drug to reach market.
Genzyme, a Sanofi company, today announced it has received European Commission approval of a product label expansion for the use of Thyrogen®.
NEW YORK (AP) — Isis Pharmaceuticals Inc. said Tuesday that it will get $1.1 million from Alnylam Pharmaceuticals Inc. as part of Alnylam's new collaboration with Genzyme.
Drug developer Isis Pharmaceuticals Inc. and partner Genzyme said Thursday a panel of advisers to the Food and Drug Administration had voted 9 to 6 to recommend approval of Kynamro, for treating patients genetically predisposed to have sky-high LDL, or bad cholesterol.
Genzyme, a Sanofi company, announced today that the FDA has approved AUBAGIO® (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS).
Impax Laboratories, Inc. today announced that it has reached agreement with Genzyme, a Sanofi company, to settle pending U.S. litigation with regard to the production and sale of generic formulations of RENVELA® (sevelamer carbonate 800 mg tablet and oral suspension 2.4g and 0.8g) and RENAGEL® (sevelamer hydrochloride 400 mg and 800 mg tablets).
Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., announced today that the FDA has accepted for filing the New Drug Application (NDA) for KYNAMRO™ (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The NDA filing with the FDA triggers a $25 million milestone payment to Isis from Genzyme.
Genzyme , a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced Thursday that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved a second suite for filling and finishing product at its Waterford, Ireland manufacturing plant.
Genzyme, a Sanofi company, today announced that its Biologics Support Center in Framingham, Mass., received a Gold certification under the U.S. Green Building Council's LEED ® (Leadership in Energy and Environmental Design) Green Building Rating System™. This is the tenth Genzyme building to achieve a LEED rating for sustainable construction and design.
Genzyme, a Sanofi company, today announced that it has begun shipping Fabrazyme® (agalsidase beta) produced at its newly approved plant in Framingham, Massachusetts.
Genzyme has announced that the EMA has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme(R).
Genzyme, a Sanofi company, and Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit affiliate of the Cystic Fibrosis Foundation, today announced a research agreement to support the discovery of new drugs to treat people with the most common mutation found in patients with CF, Delta F508.
Genzyme announced today the appointment of William "Bill" Sibold as Head of Multiple Sclerosis and Rogerio Vivaldi as Head of Rare Diseases. Both will report to David Meeker, President and Chief Executive Officer of Genzyme, and will join the Genzyme Executive Team. The MS and Rare Disease businesses constitute Genzyme's core focus following its integration with Sanofi.
Sanofi announced Monday the appointment of current Genzyme COO David Meeker to the role of CEO of Genzyme effective November 1. Meeker will report to Sanofi CEO Christopher A. Viehbacher, who will retain the position of chairman of Genzyme.
PTC Therapeutics, Inc. and Genzyme, a Sanofi company, announced today the restructuring of their collaboration.
CAMBRIDGE, Mass. (AP) — Aveo Pharmaceuticals Inc. said today it appointed Henri Termeer, the outgoing chairman, CEO and president of Genzyme Corp., to the Aveo board of directors.
Genzyme Corporation announced today that its Board of Directors unanimously recommends that Genzyme shareholders accept the sanofi-aventis revised tender offer to purchase all outstanding shares of Genzyme common stock for $74.00 and one contingent value right, per share.
CAMBRIDGE, Mass. (AP) —Genzyme Corp. said today that it completed the sale of its pharmaceutical intermediates business, finishing a plan announced last year to sell three businesses so it can focus on core growth areas.
The strategic reasons behind the acquisition in the works for Sanofi to purchase Genzyme are clear. It was a matter of fixing a sale price that reflected the true current and future value of Genzyme.
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