Agensys, Inc.
Agensys, Inc., a subsidiary of Astellas Pharm
2225 Colorado Avenue
Santa Monica
California
90404
United States
Tel: 310-820-8029
Fax: 310-382-2802
Website: http://www.urogenesys.com/
Email: info@urogenesys.com
54 articles about Agensys, Inc.
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Biopharma and life sciences companies from across the globe provide updates on their pipelines and businesses.
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Astellas' XOSPATA® (gilteritinib) Meets Overall Survival Endpoint in COMMODORE Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
3/29/2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that a Phase 3 confirmatory trial of XOSPATA® (gilteritinib) in patients with relapsed (disease that has returned) or refractory (resistant to treatment) FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) met its primary endpoint of overall survival (OS) compared to chemotherapy at a planned interim analysis.
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Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)
3/26/2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq® Granules
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Astellas Oncology Announces Grand Prize Winner of Fifth Annual C³ Prize® Challenge
3/24/2021
- Three innovators awarded $200,000 in total grants and resources for their work to Change Cancer Care beyond medicine -
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Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women
2/19/2021
Astellas Pharma Inc. (TSE: 4503) (President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 pivotal SKYLIGHT 1™ and SKYLIGHT 2™ clinical trials for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) – i.e., hot flashes associated with menopause.
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Moderate to severe vasomotor symptoms (VMS), also known as hot flashes, have long been a problem by people facing menopause.
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Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer
2/18/2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV®
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Seagen and Astellas Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy
2/12/2021
Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced results from the second cohort (cohort 2) of patients in the pivotal phase 2 single-arm EV-201 trial. In the trial, 52 percent of patients who received PADCEV®
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Seagen and Astellas Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer
2/12/2021
Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced primary results from the phase 3 EV-301 trial comparing PADCEV® (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
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Astellas and Seagen Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy
2/12/2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced results from the second cohort (cohort 2) of patients in the pivotal phase 2 single-arm EV-201 trial. In the trial, 52 percent of patients who received PADCEV®
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Astellas and Seagen Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer
2/12/2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced primary results from the phase 3 EV-301 trial comparing PADCEV®
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While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses.
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Clinical Catch-Up: October 19-23
10/26/2020
It was another busy week for clinical trial updates and news. Here’s a look. -
Clinical Catch-Up: October 12-16
10/19/2020
It was another busy week for both COVID-19-related clinical trial news as well as trial updates for other indications. Here’s a look. -
Astellas Oncology Opens Annual C3 Prize® Call for Entries to Award the Best Innovations in Cancer Care Beyond Medicine
8/4/2020
Astellas Pharma US, Inc. announced the call for entries for the Astellas Oncology C3 Prize, a global challenge that funds the best non-treatment ideas to improve cancer care for patients, caregivers and their loved ones.
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FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients
5/27/2020
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 approved VESIcare LS™ (solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older.
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Astellas Pharma US and Astellas Global Health Foundation COVID-19 Pandemic Response
4/2/2020
Astellas Pharma US, ("Astellas") and the Astellas Global Health Foundation are each expanding support for global and local communities fighting COVID-19 by providing up to $2 million of new financial assistance, in aggregate, to meet the urgent demand for resources to help patients, healthcare workers and first responders.
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CytomX Therapeutics and Astellas Announce Strategic Collaboration to Develop Probody® T-Cell Engaging Bispecific Therapies for Treatment of Cancer
3/24/2020
CytomX Therapeutics, Inc. and Astellas Pharma Inc. announced they have entered into a strategic collaboration agreement focused on the discovery, research, development and commercialization of novel T-cell engaging bispecific antibodies targeting CD3 and tumor cell surface antigens for the treatment of cancer.
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Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer
2/19/2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEV™ (enfortumab vedotin-ejfv) in combination with Merck's (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA
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Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer
2/19/2020
Feb. 19, 2020 13:12 UTC Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV ™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer - Breakthrough Therapy Designation Based on Initial Results from Phase 1b/2 EV-103 Clinical Trial - BOTHELL, Wash. & TOKYO--( BUSINESS WIRE )-- Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.