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Genzyme gets biosimilar rejection, builds R&D plant

April 22, 2008 — 5:59am ET

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Read more...

BLA Press Releases

ThromboGenics Submits Biologics License Application for Ocriplasmin to the U.S. FDA
Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for RHUCIN Biologics License Application
Research and Markets: Teva Pharmaceutical Industries Generics Company Intelligence Report 2011
Bioartificial Human Liver Therapy Trial Progressing
XIAFLEX for the Treatment of Dupuytren's Contracture Receives Priority Review From the U.S. Food and Drug Administration

Latest Headlines

Dendreon files BLA for Provenge
November 2, 2009
Auxilium's xiaflex BLA granted priority review
April 29, 2009
Ipsen inks a string of deals in expansion effort
June 5, 2008
Acambis lands $425M smallpox vaccine contract
April 23, 2008
Genzyme gets biosimilar rejection, builds R&D plant
April 22, 2008
ALSO NOTED: Ipsen files new BLA;Amgen selects Vectibix test; and much more...
March 17, 2008
Experts to weigh in on Amgen's Nplate
March 12, 2008
Medicis shares sink as FDA rejects BLA
January 31, 2008
Emerging Drug Developer: Tolerx
October 26, 2007
Press Release: Dendreon Corporation's PROVENGE Granted FDA Priority Review
January 16, 2007
Press Release: Auxilium Pharmaceuticals Amends Agreement with Cobra Biologics
November 28, 2006
Acambis shares plunge after U.S. nixes contract
November 13, 2006
SPOTLIGHT: Acambis completes vaccine BLA
April 18, 2006
UCB submits BLA for Cimzia
March 1, 2006
Anti-anemia therapy from Roche passes multiple Phase III tests
December 15, 2005
SPOTLIGHT: BLA filed for Rituxan
August 30, 2005
SPOTLIGHT: Isolagen reports mixed Phase III data
July 31, 2005
Therion pockets $30M in new round
June 16, 2005

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