Alemtuzumab news feeds

Genzyme must resubmit Lemtrada application to FDA
Boston Herald
Sanofi subsidiary, Genzyme Corp. of Cambridge, said today it has received a refuse to file letter from the U.S. Food and Drug Administration for approval of the company's multiple sclerosis drug Lemtrada. After “collaborative consultations” with the ...
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Genzyme hit with FDA setback for Lemtrada
Bizjournals.com
Lemtrada was a major negotiating point for Cambridge, Mass-based Genzyme prior to last year's acquisition deal with Sanofi. Lemtrada's market potential led Sanofi to offer conditional payments to Genzyme shareholders, a clause that could increase the ...
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Genzyme's experimental MS drug receives a 'refuse to file' letter from the FDA
Boston.com
Genzyme, the Cambridge unit of French drug maker a Sanofi SA, said it has received a “Refuse to File” letter from the Food and Drug Administration in response to its application for the approval of Lemtrada as a treatment for relapsing multiple sclerosis.
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GENZYME CORPORATION : Genzyme Provides Update on U.S. LEMTRADA ...
4-traders
(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), 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) ...
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Sanofi hits a speed bump on blockbuster Lemtrada application
FierceBiotech
Just weeks after Genzyme filed its application for Lemtrada as a new treatment for multiple sclerosis, regulators have handed the NDA back, telling the biologics arm of Sanofi ($SNY) that it needs to complete a rewrite before they can properly assess it.
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Genzyme hit with FDA setback for Lemtrada - Mass High Tech ...
In a setback for Genzyme Corp.'s emerging multiple sclerosis franchise, the U.S. Food and Drug Administration will require the company to re-submit its approval ...
www.masshightech.com/.../daily3-Genzyme-hit-with-FDA-set...
Genzyme Provides Update on U.S. LEMTRADA™ Filing - Sanofi
subsidiary Genzyme announced that Genzyme has received a Refuse to File letter from ... Genzyme is developing LEMTRADA in MS in collaboration with Bayer ...
en.sanofi.com/.../31059_20120827_LEMTRADA_FDA_FILI...
Genzyme, A Unit Of Sanofi, Sees Its Multiple-Sclerosis Drug ...
Genzyme, the U.S. biotech unit of Sanofi, said the FDA asked it to resubmit its application for approval of Lemtrada, its promising MS drug candidate.
news.investors.com/.../fda-asks-genzyme-to-resubmit-lemtrada...
Genzyme Provides Update on U.S. LEMTRADA™ Filing (SNY)
Genzyme Provides Update on U.S. LEMTRADA™ Filing. CAMBRIDGE, Mass.--( BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: ...
www.fool.com/.../genzyme-provides-update-on-us-lemtrada-fi...
Genzyme Provides Update on U.S. LEMTRADA Filing | Boston ...
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company ( EURONEXT: SAN and NYSE: SNY), announced it has received a Refuse to File letter ...
boston.citybizlist.com/.../genzyme-provides-update-us-lemtrad...

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