$ALPMY News

Last published 3y ago

3y agoALPMY PFE TYO:4503Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023PR NewswireData include three late-breaking abstracts, underscoring Astellas' efforts to potentially redefine expectations for patients across its oncology portfolio TOKYO, Oct. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc.
3y agoALPMY TYO:4503Astellas Receives Positive CHMP Opinion for VEOZA™ (fezolinetant)PR NewswireFezolinetant is an investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause More than half of women ages 40 to 64 worldwide experience VMS, with rates in Europe ranging from 56% to
3y agoALPMY MTSFY TYO:4503 TYO:8801Astellas, BioLabs and Mitsui Fudosan Announce a Collaboration to Enhance the Life Science Ecosystems in Tsukuba and Kashiwa-no-ha, JapanPR Newswire- Open Innovation Hub Named SakuLabTM-Tsukuba will open at the Astellas Tsukuba Research Center - TOKYO and BOSTON, Oct. 10, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura,
3y agoALPMY SGEN TYO:4503PADCEV® (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 TrialPR Newswire– Trial results to be submitted for presentation at upcoming medical meeting – TOKYO and BOTHELL, Wash., Sept. 22, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura,
3y agoALPMY TYO:4503Two-time Emmy® Award-Winning Actor, Eric Stonestreet, Partners with Iveric Bio to Raise Awareness of Geographic Atrophy (GA)PR NewswireGA is a form of age-related macular degeneration (AMD) that causes irreversible vision loss, affecting approximately 1.5 million people in the United States1,2 Eric and his mother, Jamey, are sharing their family's
3y agoALPMY TYO:4503Iveric Bio Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic AtrophyPR NewswireGATHER2 24-month results met the primary objective of reducing the rate of GA growth in patients treated with IZERVAY compared to sham IZERVAY 24-month safety data were consistent with 12-month results, with no new
3y agoALPMY TYO:4503Astellas Venture Management and MBC BioLabs Announce the 5th Annual Astellas Future Innovator PrizePR NewswireAwardees win a year of access to a prestigious life-science incubator in San Francisco, CA and to Astellas expertise to further their researchAward helps biotech start-ups accelerate early drug discovery and research
3y agoALPMY TYO:4503Astellas Highlights VEOZAH™ (fezolinetant) Data at the 2023 Annual Meeting of The Menopause SocietyPR NewswirePooled analyses from pivotal Phase 3 SKYLIGHT™ studies provide new insights into fezolinetant for the treatment of moderate to severe VMS due to menopause Additional presentations highlight real-world data on the
3y agoALPMY TYO:4503Astellas to Invest more than €330 Million in a New State-of-the-Art Facility in Tralee, Co. Kerry. IrelandPR Newswire- Investment will build capabilities to supply the Astellas global market and accelerate the development and commercialisation of innovative medicines - TOKYO, Sept. 14, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:
3y agoALPMY PFE TYO:4503European Medicines Agency Validates Type II Variation for Astellas' XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical RecurrencePR NewswireApplication based on results from Phase 3 EMBARK trial, which showed XTANDI plus leuprolide reduced risk of metastasis or death by 58% TOKYO, Sept. 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and
3y agoALPMY PFE TYO:4503FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical RecurrencePR NewswireIf approved, XTANDI would become the first and only novel hormone therapy approved in this earlier type of prostate cancer NEW YORK and TOKYO, Aug. 23, 2023 /PRNewswire/ -- Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc.
3y agoALPMY TYO:4503European Medicines Agency Accepts Iveric Bio's Marketing Authorization Application for Avacincaptad Pegol for Geographic AtrophyPR NewswireTOKYO, Aug. 18, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the European Medicines Agency (EMA) has accepted for regulatory review the
3y agoALPMY TYO:4503Astellas to Open New Life Sciences Facility in DivcoWest's Cambridge Crossing NeighborhoodPR NewswireTOKYO and SAN FRANCISCO, Aug. 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and DivcoWest, a DivCore Capital Company, announced today plans for Astellas to
3y agoALPMY PSTX TYO:4503Astellas and Poseida Therapeutics Announce Strategic Investment to Support Poseida's Commitment to Redefining Cancer Cell TherapyPR NewswirePoseida is a clinical-stage biotechnology company dedicated to advancing a new class of cancer cell therapy and gene therapy products using genetic engineering technologies Astellas to invest a total of $50 million to
3y agoALPMY TYO:4503Iveric Bio Receives U.S. FDA Approval for IZERVAY™ (avacincaptad pegol intravitreal solution), a New Treatment for Geographic AtrophyPR NewswireIZERVAY is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials IZERVAY slowed loss of photoreceptors
3y agoALPMY TYO:4503China's National Medical Products Administration Accepts Astellas' Biologics License Application for ZolbetuximabPR NewswireTOKYO, July 31, 2023 /PRNewswire/ -- 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
3y agoALPMY TYO:4503Astellas and Eko Health Announce Agreement to Incorporate Next Generation Eko CORE 500™ Digital Stethoscope into Z1608, an Innovative Solution Under Development for Heart Failure Patients Built on Welldoc's Proven Digital Therapeutic PlatformPR NewswireTOKYO, EMERYVILLE, Calif. and COLUMBIA, Md., July 18, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Eko Health Inc. (Co-Founder and CEO: Connor Landgraf,
3y agoALPMY TYO:4503European Medicines Agency Accepts Astellas' Marketing Authorization Application for ZolbetuximabPR NewswireTOKYO, July 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Medicines Agency (EMA) has accepted for regulatory review the
3y agoALPMY ISEE TYO:4503Astellas Completes Acquisition of Iveric BioPR NewswireTOKYO and PARSIPPANY, N.J. , July 11, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has successfully completed the acquisition of
3y agoALPMY FDMT TYO:4503Astellas and 4D Molecular Therapeutics (4DMT) Enter into License Agreement to Use 4DMT's Proprietary Intravitreal R100 Vector for Rare Ophthalmic TargetsPR NewswireTOKYO and EMERYVILLE, Calif., July 10, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) (President and CEO: Naoki Okamura, "Astellas") and 4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) (CEO: David Kirn, MD,
3y agoALPMY TYO:4503Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License ApplicationPR NewswireIf approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, July 6, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President
3y agoALPMY MTSFY TYO:4503 TYO:8801Astellas Establishes Open Innovation Hub for Tumor Microenvironment Research with Cutting-Edge Spatial Biology, in Mitsui Fudosan's "MITSUI LINK-Lab KASHIWA-NO-HA 1"PR NewswireTOKYO, June 29, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Mitsui Fudosan Co., Ltd. (TSE: 8801, President and CEO: Takashi Ueda, "Mitsui
3y agoALPMY TYO:4503Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to MenopausePR NewswireStudy evaluated 24-week efficacy and safety of Astellas' fezolinetant in women considered unsuitable for hormone therapy TOKYO, June 27, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki
3y agoALPMY TYO:4503Astellas and Cullgen Enter into Strategic Collaboration and Option Agreement to Advance Innovative Targeted Protein DegradersPR NewswireTOKYO and SAN DIEGO, June 14, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Cullgen Inc. (President and CEO: Ying Luo, Ph.D., "Cullgen") today
3y agoALPMY TYO:4503Gilteritinib as Maintenance Therapy Demonstrated Benefit in Subgroups of FLT3-ITD Acute Myeloid Leukemia PatientsPR NewswireData from Phase 3 MORPHO trial selected for press briefing and to be presented as oral session during the 2023 European Hematology Association (EHA) Hybrid Congress Exploratory results demonstrated improvement of
3y agoALPMY TYO:4503Astellas Submits New Drug Application for Zolbetuximab in JapanPR NewswireMinistry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, June 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503,
3y agoALPMY TYO:4503Astellas and Kate Therapeutics Announce Exclusive License Agreement for KT430PR NewswireKT430 is a preclinical, next-generation investigational gene therapy to treat X-linked myotubular myopathy (XLMTM) TOKYO and SAN DIEGO, June 8, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO:
3y agoALPMY TYO:4503Astellas Announces Commitments to 3rd Phase of GHIT Fund ReplenishmentPR NewswireTOKYO, May 25, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has committed to supporting the 3rd phase of the Global Health Innovative
3y agoALPMY TYO:4503Sony and Astellas Enter into Collaborative Research Agreement to Discover a Novel ADC Platform for the Oncology FieldPR NewswireConduct collaborative research on Sony's unique polymeric materials to achieve high-DAR ADC TOKYO, May 16, 2023 /PRNewswire/ -- Sony Corporation (President and CEO: Kimio Maki, "Sony") and Astellas Pharma
3y agoALPMY TYO:4503Sony and Astellas Enter into Collaborative Research Agreement to Discover a Novel ADC Platform for the Oncology FieldPR Newswire- Conduct collaborative research on Sony's unique polymeric materials to achieve high-DAR ADC - TOKYO, May 16, 2023 /PRNewswire/ -- Sony Corporation (President and CEO: Kimio Maki, "Sony") and Astellas Pharma
3y agoALPMY TYO:4503Astellas' VEOZAH™ (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to MenopausePR NewswireVEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause TOKYO, May 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki
3y agoALPMY ISEE TYO:4503Astellas Enters into Definitive Agreement to Acquire Iveric BioPR Newswire-Companies to Create World-Class Ophthalmology Entity- -Lead Program, Avacincaptad Pegol for the Potential Treatment of Geographic Atrophy with PDUFA Goal Date of August 19, 2023- -Acquisition advances Astellas'
3y agoALPMY PFE TYO:4503XTANDI® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus LeuprolidePR NewswireData from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting Results show the potential for XTANDI to add to the standard of care in prostate cancer,
3y agoALPMY TYO:4503Results from Astellas' Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The LancetPR NewswireTOKYO, April 14, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that The Lancet published detailed data from the Phase 3 SPOTLIGHT trial
3y agoALPMY TYO:4503CiRA, Kyoto University and Astellas Second Phase Joint Research Agreement Signed for Medical Applications of iPS CellsPR NewswireKYOTO, Japan and TOKYO, April 11, 2023 /PRNewswire/ -- The Center for iPS Cell Research and Application, Kyoto University (Director: Dr. Jun Takahashi; "CiRA") and Astellas Pharma Inc. (TSE: 4503, President and
3y agoALPMY SGEN TYO:4503FDA Grants Accelerated Approval for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Locally Advanced or Metastatic Urothelial CancerPR Newswire– First treatment option combining an antibody-drug conjugate plus a PD-1 inhibitor in this patient population – TOKYO and BOTHELL, Wash., April 3, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO:
3y agoALPMY TYO:4503Astellas and Roche Diabetes Care Japan ink partnership agreement to develop and commercialize integrated diabetes self-management solution with BlueStar®PR Newswire- Accu-Chek® Guide Me glucose meter to be paired with BlueStar® in Japan, which is being jointly developed by Astellas and Welldoc - - Initiation of clinical trial planned for fiscal year 2023 - TOKYO and
3y agoALPMY TYO:4503Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary SeriesPR NewswireData shows investigational zolbetuximab plus CAPOX reduced risk of progression or death by 31.3% vs CAPOX alone Study evaluated patients with Claudin 18.2-positive, HER2-negative, locally advanced unresectable or
3y agoALPMY PFE TYO:4503Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate CancerPR NewswirePfizer and Astellas announce positive topline results from Phase 3 EMBARK trial NEW YORK and TOKYO, March 16, 2023 /PRNewswire/ -- Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji
3y agoALPMY TYO:4503Results from Astellas' Pivotal Phase 3 SKYLIGHT 1™ Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The LancetPR NewswireTreatment with fezolinetant resulted in statistically significant reductions in the frequency and severity of VMS and improvements in quality of life TOKYO, March 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:
3y agoALPMY PFE TYO:4503Astellas Announces Phase 3 China ARCHES Study of XTANDI® Meets Primary EndpointPR NewswireXTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT Study enrolled 180 men with metastatic hormone-sensitive prostate cancer in
3y agoALPMY SGEN TYO:4503Astellas and Seagen Announce China's National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial CancerPR Newswire– Clinical data submitted are consistent with global data and support enfortumab vedotin as a platinum-free option in patients with locally advanced or metastatic urothelial cancer who received prior treatment with a
3y agoALPMY TYO:4503Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of GilteritinibPR NewswireTOKYO and ROCKVILLE, Md., March 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
3y agoALPMY TYO:4503Astellas Announces Update on Preliminary Safety and Efficacy Data from FORTIS Study of Investigational AT845 in Adults with Late-Onset Pompe DiseasePR NewswireData presented at the 19th Annual WORLDSymposium™ 2023 TOKYO, Feb. 22, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced an update
3y agoALPMY TYO:4503Astellas Provides Update on Fezolinetant New Drug Application in U.S.PR NewswireTOKYO, Feb. 19, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the U.S. Food and Drug Administration (FDA) notified the company that it
3y agoALPMY TYO:4503Astellas Commits to Achieve Net Zero Greenhouse Gas Emissions by 2050PR NewswireTOKYO, Feb. 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced its commitment to achieve net zero greenhouse gas (GHG) emissions by
3y agoALPMY TYO:4503Astellas Announces Change of President and CEO and Management StructurePR NewswireTOKYO, Feb. 5, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that at a meeting of its Board of Directors, held today, approved changes
3y agoALPMY TYO:4503Astellas Transfers MYCAMINE® Product WorldwidePR NewswireTOKYO, Jan. 23, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that Astellas and Sandoz AG ("Sandoz") have entered into an
3y agoALPMY TYO:4503Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe DiseasePR NewswireTOKYO, Jan. 20, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical
3y agoALPMY TYO:4503Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers SymposiumPR NewswireData shows investigational zolbetuximab reduced risk of progression or death by 24.9% Study evaluated patients with Claudin 18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or