Astex Pharmaceuticals, Inc.
299 articles with Astex Pharmaceuticals, Inc.
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Astex Announces That the Phase 3 ASCERTAIN - Acute Myeloid Leukemia (AML) Clinical Study of Oral Hypomethylating Agent Decitabine and Cedazuridine Fixed-Dose Combination (ASTX727 or DEC-C) Met the Trial’s Primary Endpoint
5/12/2022
Astex Pharmaceuticals, Inc. announces today top-line results from the ASCERTAIN phase 3 study evaluating oral decitabine and cedazuridine fixed-dose combination (ASTX727 or DEC-C) tablets versus IV decitabine in adults with AML who are not candidates to receive standard induction chemotherapy.
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Oral Decitabine and Cedazuridine (ASTX727) Granted Orphan Drug Designation (ODD) by the European Commission for the Treatment of Acute Myeloid Leukemia (AML)
1/6/2022
Astex Pharmaceuticals, Inc. announces that the European Commission has granted orphan-drug designation to the oral fixed dose combination of decitabine and cedazuridine for the treatment of Acute Myeloid Leukemia.
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Astex Pharmaceuticals Presents Overall Survival Data From ASCERTAIN Phase 3 Study of Oral Hypomethylating Agent INQOVI® (decitabine and cedazuridine) in MDS and CMML at International Congress on Myelodysplastic Syndromes
9/23/2021
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, today announced updated clinical data, including median overall survival (mOS), from the ASCERTAIN phase 3 trial of INQOVI®.
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Recro Enters Development Agreement With Astex Pharmaceuticals
5/18/2021
Recro Pharma, Inc. (“Recro”; NASD: REPH ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, today announced the signing of a new development agreement with Astex Pharmaceuticals, Inc.
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Taiho Oncology and Astex Pharmaceuticals To Present Data In Myelodysplastic Syndromes at the 62nd ASH Annual Meeting and Exposition
12/2/2020
Taiho Oncology, Inc. and Astex Pharmaceuticals, Inc. today announced that data for oral decitabine and cedazuridine (INQOVI® [decitabine and cedazuridine] 35mg/100mg tablets) in intermediate and high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) will be presented during the 62nd Annual American Society of Hematology Meeting and Exposition (ASH 2020),
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Astex Pharmaceuticals Expands Clinical Evaluation of Oral Decitabine and Cedazuridine Tablets Through New Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI)
10/28/2020
NCI has announced availability to investigators of oral decitabine and cedazuridine tablets for clinical and nonclinical study proposals under the CRADA The collaboration is intended to study oral decitabine and cedazuridine tablets in a range of tumor types
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Astex and Otsuka Announce Results of Phase 3 ASTRAL-2 and ASTRAL-3 Studies of Guadecitabine (SGI-110) in Patients with Previously Treated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes
10/14/2020
Guadecitabine did not meet the primary endpoint of improvement in overall survival versus comparator in either study Evaluating options for the future of the guadecitabine program PLEASANTON, Calif. & TOKYO--( BUSINESS WIRE )-- Astex Pharmaceuticals, Inc., a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co., Ltd., today announce top-line results of the ASTRAL-2 and ASTRAL-3 clinical studies that evaluated the effic
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Astex Pharmaceuticals and MD Anderson Announce Strategic Collaboration to Accelerate Clinical Evaluation of Therapies for Patients with Leukemia
9/8/2020
Astex Pharmaceuticals, Inc., and The University of Texas MD Anderson Cancer Center announces a strategic collaboration agreement aimed at accelerating the clinical evaluation of Astex’s pipeline of products for patients with certain types of leukemia, including myelodysplastic syndromes, chronic myelomonocytic leukemia and acute myeloid leukemia.
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Astex Pharmaceuticals Announces That Tolinapant (ASTX660), a Novel Antagonist of Cellular and X-linked Inhibitors of Apoptosis Proteins, Has Been Granted Orphan Drug Designation for the Treatment of T-cell Lymphomas by the US FDA
8/31/2020
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd., based in Tokyo, Japan, announces that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s novel, orally administered non-peptidomimetic antagonist of the cellular and X-linked inhibitors of apoptosis proteins (cIAP1/2 and XIAP)
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Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical Announce FDA and Health Canada Approval of INQOVI® (Decitabine and Cedazuridine) Tablets, Oral Hypomethylating Agent (HMA) Therapy for Intermediate and High-Risk MDS and CMML
7/8/2020
Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI® (decitabine and cedazuridine) tablets
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Immuneering Enters Collaboration with Astex Pharmaceuticals to Identify Novel Therapeutic Targets in Central Nervous System Disorder Using Disease Cancelling Technology
6/25/2020
Immuneering Corporation announced a collaboration between its neuroscience division, known as Alleo Labs, and Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., to identify novel therapeutic targets for an undisclosed neurodegenerative disease.
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A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.
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Astex Pharmaceuticals Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of an NDA for the Combination Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727 or oral C-DEC), for the Treatment of MDS and CMML
2/11/2020
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan, announced that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML.
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Merck Establishes Strategic Oncology Collaboration with Taiho and Astex
1/6/2020
Merck announced an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co, Ltd., and Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd., focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.
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The three-way deal is focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.
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Astex Pharmaceuticals Presents Topline Data from the ASCERTAIN Phase 3 Study of its Novel, Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727) in MDS and CMML at the American Society of Hematology Meeting in Orlando, FL.
12/9/2019
The study achieved its primary objective of decitabine systemic exposure equivalence between oral ASTX727 and IV decitabine with an oral/IV ratio of approximately 99%
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Astex Pharmaceuticals Announces That Its Novel, Oral Hypomethylating Agent ASTX727 Has Been Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes (Including Chronic Myelomonocytic Leukemia) by the US FDA
9/3/2019
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, announces that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s orally administered fixed-dose combination of cedazuridine and decitabine (ASTX727 or C-DEC) for the treatment of myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).
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Here’s a look at some of last week’s clinical trial announcements, including some from the American Society of Clinical Oncology Annual Meeting you might have missed.
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The fixed-dose combination was being evaluated in adults with intermediate and high-risk myelodysplastic syndrome and chronic myelomonocytic leukemia.
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Astex and Otsuka Announce Results of the Phase 3 ASCERTAIN Study of the Novel Oral Cedazuridine/Decitabine Fixed-Dose Combination (ASTX727) in Patients with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
6/6/2019
Astex Pharmaceuticals, Inc. announce top-line results from the ASCERTAIN phase 3 study evaluating cedazuridine and decitabine fixed-dose combination (ASTX727) vs decitabine IV in adults with intermediate and high-risk MDS or CMML.