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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 … See all stories on this topic » |
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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 … See all stories on this topic » |
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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. See all stories on this topic » |
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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) … See all stories on this topic » |
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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. See all stories on this topic » |
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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… |
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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… |
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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… |
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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… |
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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… |