Astellas Pharma US, Inc.
Northbrook
Illinois
60062
United States
742 articles about Astellas Pharma US, Inc.
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Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.
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Iveric Bio Receives U.S. FDA Approval for IZERVAY™ (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy
8/4/2023
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the U.S. Food and Drug Administration (FDA) approved IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023.
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China's National Medical Products Administration Accepts Astellas' Biologics License Application for Zolbetuximab
7/31/2023
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for zolbetuximab.
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Astellas and PeptiDream Enter into Research Collaboration and License Agreement to Discover Novel Targeted Protein Degraders
7/25/2023
Astellas Pharma Inc. (TOKYO: 4503, President and CEO: Naoki Okamura, “Astellas”) and PeptiDream Inc. (TOKYO: 4587, President and CEO: Patrick C. Reid, “PeptiDream”) today announced a research collaboration and license agreement to discover novel protein degraders for two targets selected by Astellas.
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Johnson & Johnson and Astellas are the latest companies to file suits against the Biden administration, challenging the constitutionality of the Inflation Reduction Act’s Drug Price Negotiation Program.
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Astellas and Eko Health Announce Agreement to Incorporate Next Generation Eko CORE 500™ Digital Stethoscope
7/18/2023
Astellas Pharma Inc. and Eko Health Inc. announced today that they have entered into a License & Supply Agreement for the global supply and license of Eko's latest digital stethoscope.
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European Medicines Agency Accepts Astellas' Marketing Authorization Application for Zolbetuximab
7/13/2023
Astellas Pharma Inc. today announced the European Medicines Agency (EMA) has accepted for regulatory review the company's marketing authorization application (MAA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.
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Astellas and 4D Molecular Therapeutics (4DMT) Enter into License Agreement to Use 4DMT's Proprietary Intravitreal R100 Vector for Rare Ophthalmic Targets
7/11/2023
Astellas Pharma Inc. and 4D Molecular Therapeutics, Inc. announced a license agreement under which Astellas gains rights to utilize the intravitreal retinotropic R100* vector invented by 4DMT for one genetic target implicated in rare monogenic ophthalmic disease, with options to add up to two additional targets implicated in rare monogenic ophthalmic diseases after paying additional option exercise fees.
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Astellas Completes Acquisition of Iveric Bio
7/11/2023
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has successfully completed the acquisition of IVERIC bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, "Iveric Bio") with respect to the announcement on April 30, 2023, through its indirect wholly-owned subsidiary Berry Merger Sub, Inc. (the "Acquisition").
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Following its $5.9 billion Iveric Bio buy, Astellas is leaning into the eye disease space with a licensing agreement for 4D Molecular Therapeutics’ proprietary intravitreal AAV delivery system.
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Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application
7/6/2023
Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has accepted and granted Priority Review for the company's Biologics License Application for zolbetuximab, a first-in-class investigational Claudin 18.2 -targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
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Astellas Establishes Open Innovation Hub for Tumor Microenvironment Research with Cutting-Edge Spatial Biology, in Mitsui Fudosan's "MITSUI LINK-Lab KASHIWA-NO-HA 1"
6/29/2023
Astellas Pharma Inc. and Mitsui Fudosan Co., Ltd. announced that Astellas will establish a "TME imaging and interactive research for innovation " open innovation hub in October, 2023 in "MITSUI LINK-Lab KASHIWA-NO-HA 1" operated by Mitsui Fudosan.
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Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to Menopause
6/28/2023
Astellas Pharma Inc. announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms due to menopause.
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9 Top M&As in the First Half of 2023
6/28/2023
Despite a challenging economic climate and gloomy forecast, 2023 has still notched some mega-deals for biopharmas. BioSpace highlights the biggest deals in the industry this year. -
The Japanese biopharma is diving deeper into targeted protein degradation, paying $35 million upfront for access to Cullgen’s uSMITE platform.
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Astellas and Cullgen Enter into Strategic Collaboration and Option Agreement to Advance Innovative Targeted Protein Degraders
6/15/2023
Astellas Pharma Inc. and Cullgen Inc. announced a research collaboration and exclusive option agreement to discover multiple innovative protein degraders.
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Gilteritinib as Maintenance Therapy Demonstrated Benefit in Subgroups of FLT3-ITD Acute Myeloid Leukemia Patients
6/9/2023
Astellas Pharma Inc. and the Blood and Marrow Transplant Clinical Trials Network presented data from the Phase 3 MORPHO clinical trial which demonstrated favorable results in subgroups of FMS-like tyrosine kinase 3 -internal tandem duplication mutated acute myeloid leukemia patients, including a subgroup of patients with detectable measurable residual disease.
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Astellas Submits New Drug Application for Zolbetuximab in Japan
6/9/2023
Astellas Pharma Inc. announced the submission of a New Drug Application on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare for zolbetuximab, a first-in-class investigational Claudin 18.2 -targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
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Kate Therapeutics Debuts With $51 Million Series A to Develop Next-Generation Genetic Medicines to Treat Muscle and Heart Diseases
6/8/2023
Kate Therapeutics Inc., a next-generation gene therapy company, emerged from stealth mode with a $51 million Series A financing co-led by founding investor Westlake Village BioPartners and Versant Ventures, with participation from Osage University Partners and UF Innovate | Ventures.
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Astellas and Kate Therapeutics Announce Exclusive License Agreement for KT430
6/8/2023
Astellas Pharma Inc., and Kate Therapeutics announced an exclusive license agreement to develop and commercialize KT430.