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Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter
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Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
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Astellas Pharma’s Vyloy Receives FDA Approval for Gastric Cancer Treatment in CLDN18.2 Positive Tumors
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its drug Vyloy (zolbetuximab-clzb). The approval is for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally…
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Astellas Pharma Employee in China Formally Indicted on Espionage Suspicion
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Astellas Pharma Inc., a Japanese pharmaceutical company listed on the Tokyo Stock Exchange (TYO: 4503), is facing a challenging situation as one of its employees, detained in China since March 2023 on suspicion of espionage, has reportedly been formally indicted by Chinese authorities. The news was reported by Reuters, citing…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
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Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2). According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a…
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Pfizer, Astellas, and University of California Sue Qilu Pharma Over Xtandi Patent Infringement
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Pfizer Inc. (NYSE: PFE), through its subsidiary Medivation, and co-development partner Astellas Pharma Inc. (TYO: 4503), are stepping up their efforts to safeguard the intellectual property of their blockbuster prostate cancer drug, Xtandi (enzalutamide). In a joint legal action with the University of California, the companies have filed a lawsuit…
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Astellas Pharma Reports Robust Q1 FY2024 Results, Highlighting Growth in Core Therapies
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced its financial results for the first quarter of the fiscal year 2024, ending June 30, 2024. The company reported a robust performance with a 26.2% increase in global sales, reaching JPY 473,124 million (USD 3.16 billion) compared to the same period last…
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Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
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Astellas Resubmits FDA Application for Vyloy as Treatment for CLDN18.2-Positive Cancer
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic Vyloy (zolbetuximab) to the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This resubmission follows an earlier rejection and comes…
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Astellas Pharma Considers Joint Cell Therapy Platform with Yaskawa Electric
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it is in advanced discussions with fellow Japanese firm Yaskawa Electric Corporation (OTCMKTS: YASKY) to explore a potential collaboration aimed at developing a cell therapy platform. This strategic partnership would integrate robotics technologies to expedite research and…
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Astellas Invests USD 90 Million in New US Facility to Boost Research and Commercialization
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Japanese pharmaceutical company Astellas Pharma Inc. (TYO: 4503) has inaugurated a state-of-the-art laboratory and office facility in the United States, marking a significant step in the company’s commitment to research and development. The new 14,307 sq.m. site represents an investment of USD 90 million and will serve as a hub…
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Astellas Pharma Inc. Reports Revenue Growth in FY2023, Driven by Xtandi and Padcev Sales
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced its financial results for the year ended March 31, 2024, with revenues reaching ¥1.603 trillion (USD 10.13 billion), marking a 5.6% year-on-year (YOY) increase. The company’s core growth drivers for the year included the prostate cancer drug Xtandi (enzalutamide), which is co-developed…
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Takeda and Astellas Join Forces with Sumitomo Mitsui to Launch Drug Discovery Joint Venture
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Japanese pharmaceutical giants Takeda (NYSE: TAK) and Astellas (TSE: 4503) have joined hands with compatriot bank Sumitomo Mitsui to establish a joint venture (JV) aimed at nurturing drug discovery start-ups. The yet-to-be-named JV will leverage the pharmaceutical companies’ expertise to foster innovation in the early stages of drug development.- Flcube.com
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Astellas Pharma’s Padcev Combo Therapy Accepted for Review in China for Urothelial Carcinoma
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center for Drug Evaluation (CDE) has accepted for review a supplementary Biologic License Application (sBLA) for its drug Padcev (enfortumab vedotin). The application seeks to expand the use of Padcev in combination with pembrolizumab for the…
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Bayer’s Elinzanetant Achieves Primary Endpoint in Late-Stage Menopause Symptom Trial
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Bayer (ETR: BAYN), a leading German pharmaceutical company, has announced positive results from a placebo-controlled late-stage trial of its NK-1,3 receptor antagonist, elinzanetant. The trial successfully met its primary endpoint, demonstrating a significant reduction in the frequency of moderate-to-severe vasomotor symptoms (VMS) associated with menopause by week 12. The 52-week…
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Astellas Launches Late-Stage Trial in Japan for Nonhormonal Menopause Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, last week initiated a late-stage trial in Japan for fezolinetant, a neurokinin B (NKB) blocker, as a potential treatment for vasomotor symptoms (VMS) associated with menopause in women. This placebo-controlled study aims to evaluate the efficacy and safety of the…
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Astellas Pharma Partners with Kelonia Therapeutics to Advance CAR-T Cell Therapies
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Astellas Pharma Inc. (TYO: 4503) has announced a strategic research collaboration and licensing agreement with U.S.-based biotech company Kelonia Therapeutics. The partnership, established through Astellas’ subsidiary Xyphos Biosciences, will leverage Kelonia’s proprietary in vivo gene placement system (iGPS) to engineer advanced lentiviral particles for targeted genetic delivery, in conjunction with…
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Astellas Pharma Inc. Reports 2.1% YOY Growth in Q1-Q3 Fiscal 2023 Revenues
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Tokyo-based pharmaceutical company Astellas Pharma Inc., (TYO: 4503) has announced financial results for the first three quarters of its fiscal year 2023, ending December 31, 2023. The corporation reported a year-on-year (YOY) increase of 2.1% in global revenues, reaching JPY 1,189 billion (USD 8 billion) over the nine-month period. Astellas’…
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Astellas Pharma Inc. Reports 2.1% YOY Growth in Q1-Q3 Fiscal 2023 Revenues
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Japanese pharmaceutical corporation Astellas Pharma Inc., (TYO: 4503) has announced its financial results for the first three quarters of its fiscal year 2023, concluding on December 31, 2023. The company has experienced a modest 2.1% year-on-year (YOY) increase in global revenues, totaling JPY 1,189 billion (USD 8 billion) for the…
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Astellas Forges Partnership with Mass General Brigham to Boost Oncology and Rare Disease Research
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced a strategic partnership with Mass General Brigham, a prominent academic institution in the United States. This collaboration aims to drive scientific and clinical advancements in critical areas, including oncology, rare diseases, and cell and gene therapy. Astellas will…
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Astellas Pharma Appoints Zhao Ping as Chairman of China Operations
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Effective January 15, 2024, Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has appointed Zhao Ping as the chairman of its China operations. This strategic appointment comes as the company looks to strengthen its presence and leadership in the Chinese market. Zhao Ping brings a wealth of experience to…
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Astellas’ Zolbetuximab Faces FDA Rejection Due to Manufacturing Facility Deficiencies
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The US Food and Drug Administration (FDA) has issued a rejection for a filing submitted by Astellas (TYO: 4503), a Japanese pharmaceutical company, for its first-in-class anti-CLDN18.2 biologic zolbetuximab. The drug was under consideration for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ)…
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Elpiscience Partners with Astellas for Bi-Specific Macrophage Engager Research
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China-based Elpiscience Biopharmaceuticals has announced a research collaboration and licensing agreement with Japan’s Astellas Pharma Inc. (TYO: 4503), focusing on Elpiscience’s innovative bi-specific macrophage engager, ES019, along with another program. The partnership will involve joint early-stage research on these two initiatives, with Elpiscience granting Astellas the option to include up…
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Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
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Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high…
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Astellas Pharma Acquires Propella Therapeutics for $175 Million to Boost Prostate Cancer Treatment
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Japan’s Astellas Pharma (TYO: 4503) has announced the negotiation of a purchase agreement for US biopharmaceutical company Propella Therapeutics this week, with a transaction value of USD 175 million. The deal is anticipated to be finalized by March 2024, subject to the fulfillment of customary conditions. With this acquisition, Astellas…
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Astellas Pharma Inc. Reports Moderate Revenue Growth in H1 Fiscal 2023 Financials
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Japan-based Astellas Pharma Inc., (TYO: 4503) has released its financial results for the first half (H1) of fiscal 2023, which ended on September 30, 2023. The company reported a modest year-on-year (YOY) increase in global revenues, reaching JPY 767.14 billion (USD 5.1 billion), marking a growth of just 0.6%. Performance…
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Astellas Pharma’s Xtandi NDA for mHSPC Treatment Accepted by China’s CDE
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) has accepted for review the New Drug Application (NDA) for its medication Xtandi (enzalutamide), which is intended for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). NDA Basis and Study ResultsThe NDA is…
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Astellas Pharma Invests EUR 330 Million in State-of-the-Art Manufacturing Plant in Ireland
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Japanese pharmaceutical company Astellas Pharma (TYO: 4503) has announced a significant investment of EUR 330 million (USD 352 million) to construct a new manufacturing plant in Ireland. This strategic move aims to enhance the company’s production capacity and ensure a stable global supply of its pharmaceutical products. The state-of-the-art facility…
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EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
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The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval for its androgen receptor inhibitor Xtandi (enzalutamide). This approval expands the use of Xtandi as a treatment for non-metastatic hormone-sensitive prostate cancer (nmHSPC) in patients with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.…
