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March 14, 2014
17:33 EDTTKPYY, SCMPSucampo, Takeda say that Amitiza NDA will not be filed in second half of 2014
Sucampo Pharma Americas, a wholly owned subsidiary of Sucampo Pharmaceuticals (SCMP), and its development and commercialization partner's subsidiary Takeda Pharmaceuticals (TKPYY) announced that the New Drug Application, NDA, for the liquid formulation of Amitiza will not be filed in the second half of 2014. In preliminary pre-NDA meeting comments, the FDA informed Sucampo that it would require additional data to characterize pharmacokinetics of the new formulation. As a result of this outcome in conjunction with the FDA feedback, Sucampo and Takeda are now assessing next steps, which may include formulation modification.
News For SCMP;TKPYY From The Last 14 Days
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December 7, 2014
13:23 EDTTKPYYSeattle Genetics, Takeda announce four-year data from ADCETRIS trial
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12:44 EDTTKPYYSeattle Genetics, Takeda report Phase 3 AETHERA trial data from Adcetris
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12:33 EDTTKPYYTakeda formalizes 'Takeda Oncology' to meet needs of cancer patients
Takeda Pharmaceutical announced its global oncology business unit, headquartered in Cambridge, MA, will be called Takeda Oncology. The creation of Takeda Oncology will improve the company’s ability to meet the unique and urgent needs of cancer patients, their loved ones and health care providers worldwide. Takeda will sustain its long-standing entrepreneurial approach to oncology research and development while expanding its global commercial network and resources as Takeda Oncology. Takeda is retiring the Millennium: The Takeda Oncology Company brand, and replacing it with Takeda Oncology to reflect the new global oncology business unit. “Despite the progress made in the fight against cancer, serious unmet needs persist across many forms of the disease,” said Christophe Bianchi, M.D., President, Global Oncology Business Unit. “Takeda Oncology has a deep understanding of patient needs and applies scientific rigor and resources to work to meet these needs. Now, our agile business model optimally organizes us to quickly meet the diverse needs of cancer patients, health care providers and systems around the world, and bring the next generation of cancer treatments to cancer patients who need them.”

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