Dublin And Lexington
DUBLIN and LEXINGTON, Massachusetts, June 24, 2011 -
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that the European
Medicines Agency has approved the purification of
REPLAGAL (agalsidase alfa) drug substance at its new
manufacturing facility in Lexington, MA, US.
DUBLIN and LEXINGTON, Massachusetts, March 21, 2011 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that the US Food and Drug
Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA)
date of August 25, 2011 for the review of the New Drug Application (NDA) for
FIRAZYR(R) (icatibant) for the treatment of acute attacks (Types I and II) of
hereditary angioedema (HAE).
DUBLIN and LEXINGTON, Massachusetts, March 3, 2011 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that the European Commission has
approved FIRAZYR for self-administration after training in subcutaneous
injection technique by a healthcare professional.
DUBLIN and LEXINGTON, Massachusetts, February 28, 2011 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that it has submitted a complete
response to the not approvable letter issued by the US Food and Drug
Administration (FDA) to Jerini AG in April 2008 regarding its New Drug
Application for FIRAZYR(R) (icatibant) for the treatment of acute attacks of
hereditary angioedema (HAE).
