Astellas Pharma US, Inc.
=
Northbrook
Illinois
60062
United States
719 articles about Astellas Pharma US, Inc.
-
The company is hoping the topline results for Veozah, which won FDA approval in May, will support health technology assessments for reimbursement negotiations in Europe.
-
Astellas' Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy
11/29/2023
Astellas Pharma Inc. will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant in an oral presentation on November 30 at the 15th Congress of the European Society of Gynecology in Amsterdam, The Netherlands.
-
Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
11/17/2023
Astellas Pharma Inc. and Pfizer Inc. announced that the companies received an approval by the U.S. Food and Drug Administration of a supplemental New Drug Application for XTANDI®, following FDA expedited development and review programs, based on results from the Phase 3 EMBARK trial.
-
Xtandi is now approved to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis with or without a gonadotropin-releasing hormone analog therapy.
-
University of Tsukuba and Astellas Confirm a Strategic Partnership
11/16/2023
University of Tsukuba and Astellas Pharma Inc. announced that they have signed a letter of confirmation regarding a strategic partnership to accelerate the digitalization of the drug discovery research field, as well as the development of the life science ecosystem in Tsukuba and Kashiwa-no-ha, and to further accelerate innovative drug discovery research and development.
-
The Japanese pharma contends that an analysis of the four deaths in its AT132 gene therapy clinical trial shows it is still viable as a potential treatment for a fatal, rare genetic disease.
-
Astellas to Acquire Propella Therapeutics
11/15/2023
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Propella Therapeutics, Inc. (President and CEO: William Moore, "Propella") today announced that Astellas, through a U.S. subsidiary, and Propella have entered into a merger agreement pursuant to which Astellas will acquire Propella.
-
Astellas Announces Data from ASPIRO Study in X-linked Myotubular Myopathy Published in The Lancet Neurology
11/15/2023
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that The Lancet Neurology published a preliminary data analysis from the ASPIRO trial, evaluating the safety and efficacy of investigational AT132 (resamirigene bilparvovec), an adeno-associated viral vector (AAV) gene replacement therapy designed to deliver a functional human MTM1 gene for the treatment of pediatric patients with X-linked myotubular myopathy (XLMTM).
-
IZERVAY™ (avacincaptad pegol intravitreal solution) Monthly or Every Other Month Reduced Geographic Atrophy Lesion Growth Through 2 Years
11/4/2023
Astellas Pharma Inc. announced results from the GATHER2 Phase 3 clinical trial, demonstrating IZERVAY™ continued to reduce the rate of geographic atrophy lesion growth for both every month and every-other-month dosing vs. sham through 2 years of treatment in patients with GA secondary to age-related macular degeneration.
-
October saw a surge of life science job activity with job applications up 65% from last year as well as a number of a significant layoff announcements.
-
KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Reduced Risk of Death by More Than Half Versus Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
10/22/2023
Merck, known as MSD outside of the United States and Canada, announced results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate, compared to chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.
-
Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) in First-Line Advanced Bladder Cancer
10/22/2023
Astellas Pharma Inc. and Seagen Inc. announced results from the Phase 3 EV-302 clinical trial for PADCEV® in combination with KEYTRUDA® versus chemotherapy.
-
Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023
10/15/2023
Astellas Pharma Inc. will share new research results during the European Society for Medical Oncology Congress 2023 from October 20-24, showcasing the company's focus on making a meaningful difference for people living with hard-to-treat cancers.
-
Astellas Receives Positive CHMP Opinion for VEOZA™ (fezolinetant)
10/13/2023
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12 adopted a positive opinion relating to the use of VEOZA™ (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
-
Astellas, BioLabs and Mitsui Fudosan Announce a Collaboration to Enhance the Life Science Ecosystems in Tsukuba and Kashiwa-no-ha, Japan
10/11/2023
Astellas Pharma Inc. and BioLabs Global, Inc. and Mitsui Fudosan announced that they have agreed on a tri-party memorandum of understanding to enhance the life science ecosystem in Tsukuba and Kashiwa-no-ha, Japan, world-renowned science hubs.
-
While Astellas did not say why it withdrew its suit, it was the only company to file a legal complaint that wasn’t on the initial IRA drug price negotiations list and may not have had any grounds to sue.
-
PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) Significantly Improve Overall Survival and Progression-Free Survival in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial
9/22/2023
Astellas Pharma Inc. and Seagen Inc. announced positive topline results from the Phase 3 EV-302 clinical trial for PADCEV® in combination with KEYTRUDA® versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer, a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.
-
Merck Announces Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
9/22/2023
Merck, known as MSD outside of the United States and Canada, announced positive topline results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.
-
The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.
-
ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.