Tag Archives: astellas

December, 2018

20 December
Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 Trial of Xtandi in Metastatic Hormone-Sensitive Prostate Cancer

TOKYO & NEW YORK–(BUSINESS WIRE)–Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the Phase 3 ARCHES trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, significantly improving …
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29 November
FDA Approves Astellas’ Xospata for Adults with Relapsed/Refractory Acute Myeloid Leukemia with a FLT3 Mutation

TOKYO, Nov. 28, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved XOSPATA® (generic name: gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia …
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23 August
Pfizer and Astellas Amend Clinical Research Protocols to Accelerate Completion Dates for Phase 3 Trials of Enzalutamide in Prostate Cancer

NEW YORK & TOKYO–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). …
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17 July
FDA Approves Xtandi for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer

TOKYO & NEW YORK–(BUSINESS WIRE)–Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase …
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31 May
FDA Grants Priority Review to Astellas’ Gilteritinib for the Treatment with Relapsed or Refractory Acute Myeloid Leukemia

TOKYO, May 29, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company’s New Drug Application (NDA) for gilteritinib for the treatment of adult patients who have relapsed or refractory (resistant …
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22 January
Astellas and Vical’s Investigational Cytomegalovirus Vaccine Fails in Late-Stage Trial in Hematopoietic Stem Cell Transplant Recipients

TOKYO and SAN DIEGO, Jan. 22, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Vical Incorporated (NASDAQ: VICL) announced today that ASP0113, an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant (HSCT) recipients, did not meet its primary or …
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28 November
Astellas to Present New Data Evaluating Gilteritinib in Newly Diagnosed AML Patients

TOKYO, Nov. 28, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) today announced new data in acute myeloid leukemia (AML) research, including preliminary results from a Phase 1 study of the investigational agent gilteritinib in combination with induction and consolidation chemotherapy in patients with …
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20 October
Astellas and Universal Cells Enter Collaboration Utilizing Universal Donor Cell Technology

TOKYO, Oct. 19, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Universal Cells, Inc. (CEO: Claudia Mitchell, “Universal Cells”) today announced that Astellas Institute for Regenerative Medicine (“AIRM”) and Universal Cells have entered into an exclusive worldwide license agreement to research, develop and …
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11 October
FDA Grants Fast Track Designation to Astellas’ Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia

TOKYO, Oct. 10, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of gilteritinib for adult patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia …
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14 September
Pfizer and Astellas Announce Positive Late-Stage Results for Xtandi in Non-Metastatic Castration-Resistance Prostate Cancer

NEW YORK & TOKYO–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the Phase 3 PROSPER trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC) met its primary endpoint …
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