Astellas Pharma US, Inc.
Northbrook
Illinois
60062
United States
746 articles about Astellas Pharma US, Inc.
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Takeda, Astellas and Sumitomo Mitsui Banking Announce Master Agreement to Establish Joint Venture Company for Incubation of Early Drug Discovery Programs
4/22/2024
Takeda Pharmaceutical Company Limited, Astellas Pharma Inc., and Sumitomo Mitsui Banking Corporation announced that the three companies signed a master agreement on April 22, 2024, to establish a joint venture company.
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Invenra Inc. Announces a Strategic Research Agreement with Astellas Pharma in Therapeutic Bispecific Antibody Discovery
4/9/2024
Invenra Inc., an innovative leader in bispecific antibody technology, is pleased to announce a strategic research agreement with Astellas Pharma, a global pharmaceutical company with a vision to turn innovative science into value for patients.
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CytomX Therapeutics Announces Nomination of Second Clinical Candidate in Broad PROBODY® T-Cell Engaging Bispecific (TCB) Collaboration with Astellas
4/3/2024
CytomX Therapeutics, Inc. today announced the achievement of a second clinical candidate nomination under the companies’ TCB collaboration with Astellas, triggering a $5 million milestone payment to CytomX.
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China's National Medical Products Administration Accepts Astellas and Pfizer's Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
3/28/2024
Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for enfortumab vedotin with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
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Astellas' VYLOY™ (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer
3/26/2024
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that on March 26, 2024, Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer.
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Astellas Receives Positive CHMP Opinion for XTANDI™ in Additional Recurrent Early Prostate Cancer Treatment Setting
3/22/2024
Astellas Pharma Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI.
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After forging a partnership last year, Astellas is ending the pact with Cartesian Therapeutics and stopping the development of a Pompe disease candidate.
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FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA® (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children
3/11/2024
Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to CRESEMBA® (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients.
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Despite the changing landscape in biopharma, many companies are still recruiting. If you’re looking to make a career change, here are 12 biopharma companies hiring on BioSpace now.
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Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan
3/3/2024
Astellas Pharma Inc. announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms associated with menopause in Japanese women.
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Astellas Names Michael Petroutsas as Head of US Commercial
2/22/2024
Astellas Pharma Inc. Chief Commercial Officer Claus Zieler has named Michael Petroutsas as Head, United States Commercial, leading the Astellas Pharma US Inc. organization.
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After a slow start to 2023 in an uncertain economic climate, biopharma mergers and acquisitions are on the rise.
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Kelonia Therapeutics’ in vivo gene placement system is being tapped to help Astellas Pharma expand its portfolio of in vivo CAR-T cell therapies for cancer.
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PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan's Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer
2/15/2024
Astellas Pharma Inc. announced that Japan's Ministry of Health, Labour and Welfare has granted priority review for the company's Supplemental New Drug Application for PADCEV™ with KEYTRUDA® as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.
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Astellas and Kelonia Therapeutics Enter into Research and License Agreement to Develop Novel Immuno-Oncology Therapeutics
2/15/2024
Astellas Pharma Inc. and Kelonia Therapeutics announced that Xyphos Biosciences, Inc., and Kelonia have entered into a research collaboration and license agreement to develop novel Immuno-Oncology therapeutics.
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Astellas Makes Announcement about Management Structure
2/6/2024
Astellas Pharma Inc. announced the following changes to its management structure effective April 1, 2024.
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Astellas Announces Strategic Collaboration with Mass General Brigham
1/30/2024
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that it has entered into a strategic collaboration with Mass General Brigham (President and CEO: Anne Klibanski, MD) that is focused on translational medicine and early development to establish an integrated approach to scientific advancement and clinical expertise.
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European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
1/26/2024
Astellas Pharma Inc. and Pfizer Inc. announced that on Jan. 26, 2024 the European Medicines Agency validated for review a Type II variation application for PADCEV™ with KEYTRUDA® as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.
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Vivtex Enters Research Collaboration with Astellas Pharma
1/23/2024
Vivtex Corporation announces that it has entered a research collaboration with Astellas Pharma Inc. (“Astellas”), a global pharmaceutical company.
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Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
1/8/2024
Astellas Pharma Inc. announced the U.S. Food and Drug Administration issued a complete response letter on January 4, 2024, regarding the Biologics License Application for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 -negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive.