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FDA Approves Shire Manufacturing Move
contractpharma
January 25, 2018
The U.S. Food and Drug Administration has granted approval for the technology transfer of Shire’s CINRYZE (C1 esterase inhibitor [human]) drug product manufacturing process to its Vienna, Austria manufacturing site.
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Shire Continues to Uphold High Standards of Ethics and Transparency With Adoption of Open Access Pol
biospace
January 24, 2018
Shire plc has implemented a new publishing policy that requires the submission of all Shire-supported research papers to open access to journals that provide public availability
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Shire Granted EU Marketing Authorization for ADYNOVI [Antihemophilic Factor (Recombinant), Pegylated
biospace
January 16, 2018
Shire plc, a world leader in disease biotechnology, today announced that the European Commission has granted marketing authorization to ADYNOVI [Antihemophilic Factor (Recombinant), PEGylated]
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Shire to Break Up Business Into Two Companies
biospace
January 10, 2018
Shire announced that it is splitting into two separate internal business units, Rare Disease Division and Neuroscience Division
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FDA Bestows Breakthrough Tag on Shire's Maribavir
biospace
January 05, 2018
Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients
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Shire Plans to Hire for its new Manufacturing Site in Georgia
biospace
December 28, 2017
Shire filed its first submission to the U.S. Food and Drug Administration (FDA) for its new plasma manufacturing site in Covington, Georgia.
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Shire Hunter syndrome therapy fails to hit study targets
pharmatimes
December 21, 2017
Shire’s investigational Hunter syndrome therapy SHP609 has failed to meet primary and secondary targets in a mid-stage trial.
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Shire's Hunter Syndrome Treatment Failed Phase II/III Goals
biospace
December 20, 2017
An experimental treatment to address cognitive impairment in pediatric patients diagnosed with the rare disease known as Hunter syndrome failed a key trial, Shire PLC announced this morning.
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Shire and partners launch Irish haemophilia study
pharmatimes
December 18, 2017
Shire, the Royal College of Surgeons Ireland (RCSI) and Science Foundation Ireland (SFI), in collaboration with the Irish Haemophilia Society, have initiated a new study that aims to better personalise the care of haemophilia patients.
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Shire, Rani to develop oral factor VIII therapy
pharmatimes
December 07, 2017
Shire and Rani Therapeutics have signed a deal to work on developing an orally-delivered therapy for patients with hemophilia A.