A

Astellas Pharma

Global pharma advancing oncology, gene therapy

Head, Medical Inquiry Content

Full-TimeUpdated on 10/23/2026
No salary listed
Expert
Master's, PharmD, PhD, MD
Tokyo, Japan
HybridHybrid work is permitted, combining office work in Nihonbashi, Tokyo, with work from home.
Biology & Biotech

About the job

Requirements
  • An advanced healthcare degree (MD, PhD, MSc, or PharmD).
  • At least 10 years of pharmaceutical industry or related experience, including at least 5 years of Medical Information experience.
  • At least 2 years of personnel management and/or group/team leader experience.
  • Thorough understanding of legal, regulatory, and compliance requirements and guidelines for medical affairs and medical communications in the pharmaceutical industry.
  • Strategic thinking and problem-solving ability, emotional intelligence, and the ability to recognize and anticipate problems.
  • Understanding of the commercial business within the therapeutic area and associated customer service needs.
  • Matrix leadership skills, including achieving business objectives through matrix teams, collaboration, and problem-solving.
  • Experience managing multiple projects efficiently.
  • Ability to communicate effectively at all organizational levels and advocate for the department and team to support effective working relationships.
  • Ability to review and understand complex scientific and medical data from clinical and non-clinical trials and summarize the content in written and verbal forms.
  • Thorough knowledge of company products and pharmaceutical industry operations.
  • Fluency in written and verbal business English and Japanese, with advanced presentation and training skills.
Responsibilities
  • Provide strategic direction for the Japan Medical Information Content Team in alignment with the global Medical Information team.
  • Ensure the Japan team delivers high-quality work compliant with evolving regulatory requirements and informed by current scientific knowledge and insights in a fair and balanced manner.
  • Cultivate an innovation and change mindset and lead the team through ambiguity and uncertainty.
  • Monitor Medical Information performance and other quantitative and qualitative metrics, including content feedback, escalation rates, and response times.
  • Build partnerships with other Medical Information team leads and cross-functional stakeholders, and foster collaboration between Medical Information teams and Evidence Dissemination Value Teams.
  • Align with matrix stakeholders on business objectives, content strategies, and deliverables.
  • Oversee local product strategies aligned with local brand strategy and Japan customer needs.
  • Manage a team creating high-quality Medical Information content for timely use across contact centers, websites, and self-service portals, optimizing global content for global products.
  • Drive creation of content tailored to customer needs and channel and format preferences.
  • Enable technology advances, including artificial intelligence for content creation, in collaboration with stakeholders.
  • Establish systematic processes for creating, reviewing, approving, and maintaining Medical Information content.
  • Monitor external environments and benchmarks for healthcare professional and customer content and channel preferences.
  • Support Medical Affairs capabilities for orchestrating omnichannel interactions that meet customer information and education needs.
  • Implement content-generation process improvements with Medical Affairs Excellence and drive content innovation based on evolving customer needs.
  • Promote integrated ways of working, reuse central content, and maintain a consistent company voice.
  • Lead and manage alliance partner discussions, align on strategic goals and performance metrics, and negotiate joint charters and rules of engagement.
  • Facilitate regular alliance partner meetings, build stakeholder relationships, and resolve partnership challenges.
  • Oversee resolution of customer complaints, provide strategic direction and resources and training, and analyze escalated cases to identify and address root causes.
  • Serve as the escalation point for critical customer issues and ensure timely, professional communication to restore customer trust and confidence.
  • Establish and review complaint, escalation outcome, and customer satisfaction key performance indicators, assess escalation procedures, and drive continuous improvement.
  • Ensure the Japan team follows Medical Information processes, procedures, and best practices aligned with legal, regulatory, and compliance requirements.
  • Coordinate with the Medical Information Enablement team on vendor- and affiliate-specific inquiry-handling matters.
  • Monitor industry trends and global and local regulations affecting responses to unsolicited customer requests, and implement necessary or innovative changes.
  • Lead a high-performing team delivering scientifically sound work across therapeutic areas.
  • Oversee resource allocation, outsourced vendor strategy for medical writing, quality control/editing and translation, and vendor budgets.
  • Assess needs, build capabilities, and manage Medical Information talent, including individual development plans and retention.
Desired Qualifications
  • Experience working in a global environment.
  • Global or multi-regional management experience.

About the company

A

Astellas Pharma

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Website

Astellas Pharma develops medicines for high-need diseases, with focus in oncology, urology, nephrology, and ophthalmology. It guides R&D with a Focus Area Approach, quickly shifting resources to promising science and backing next-generation modalities like targeted protein degradation, cell and gene therapies, and immuno-oncology, using precision medicine. It differentiates itself through openness to external partnerships, specialized innovation hubs, venture investments, and a strong ESG-driven approach to supply chain and access. Its goal is to turn scientific advances into life-changing therapies and sustain a diverse, global pipeline for patients.

Company Size

10,001+

Company Stage

IPO

Headquarters

Tokyo, Japan

Founded

1894

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Simplify's Take

What believers are saying

  • Veozah's October 2, 2026 OPTION-VMS data showed improved hot flashes and sleep.
  • Astellas and Pfizer's STEEL trial strengthened Xtandi's salvage-radiation profile at ASTRO 2026.
  • Astellas is opening its first China R&D base in Beijing, expanding candidate discovery.

What critics are saying

  • Astellas will close Universal Cells' Seattle office starting July 1, 2026, cutting 50 jobs.
  • The August 31, 2026 U.S. deal forces Medicaid price cuts and future international price indexing.
  • Xtandi and Padcev dominate cash flow; one patent loss would crush pipeline funding.

What makes Astellas Pharma unique

  • Padcev won FDA's July 10, 2026 platinum-free bladder-cancer approval with Keytruda.
  • Tralee expansion doubles aseptic filling capacity, strengthening Astellas' global manufacturing network by 2029.
  • Astellas keeps building oncology, urology, and women's-health franchises around Xtandi and Veozah.

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Benefits

  • Health Insurance
  • Employee Stock Purchase Plan
  • Commuter Benefits
  • Paid Vacation
  • Parental Leave
  • Hybrid Work Options

Company News

International Society for Pharmaceutical Engineering (ISPE)
Oct 13th, 2026
Cell & Gene covers the session, early regulatory alignment to implement next-generation sequencing at GMP scale, to be presented at the 2026 ISPE Annual Meeting & Expo.

Cell & Gene covers the session, early regulatory alignment to implement next-generation sequencing at GMP scale, to be presented at the 2026 ISPE Annual Meeting & Expo. 13 October, 2026 As cell and gene therapy developers seek faster, more comprehensive approaches to viral safety testing, next-generation sequencing (NGS) is emerging as a promising technology for detecting adventitious agents at GMP scale. The topic will be explored at the 2026 ISPE Annual Meeting & Expo, where Jihye Nam and Tracie Fradet of Astellas Pharma will discuss the opportunities and challenges associated with implementing NGS-based viral safety testing in regulated manufacturing environments. Traditional adventitious agent detection methods have long served as a cornerstone of biopharmaceutical safety, but they present several limitations. Cell culture-based assays can require weeks to generate results and depend on a virus's ability to infect specific indicator cells. Molecular assays offer faster turnaround times but generally require prior knowledge of the viral sequences being targeted. As a result, these approaches may struggle to detect unknown or unexpected contaminants and often require multiple complementary tests to achieve broad coverage. NGS offers a fundamentally different approach. Rather than searching for predefined viral targets, the technology enables broad, hypothesis-free screening for a wide range of known and potentially novel viruses in a single assay. According to Nam and Fradet, this capability provides significant advantages for cell and gene therapy manufacturers, offering high sensitivity, scalability, and the ability to generate extensive safety information from limited sample volumes. The need for improved detection methods is particularly important in cell and gene therapy manufacturing. Unlike many traditional biologic products, cell therapies often contain large amounts of host-cell DNA and RNA, creating substantial biological background noise that can obscure low-level viral contamination signals. In addition, developers frequently have very limited sample quantities available, especially when testing valuable cell banks, intermediates, or final drug products. Because each test may consume a meaningful portion of a manufacturing lot, maximizing the amount of information obtained from each sample becomes critical. NGS allows manufacturers to evaluate a broad spectrum of viral risks while minimizing sample consumption, an increasingly important advantage for advanced therapies. However, implementing NGS in GMP environments is not as simple as replacing existing assays. Cell and gene therapy processes often utilize complex materials such as viral vectors, plasmids, and cytokines, all of which can leave residual nucleic acid signatures that may appear during sequencing analyses. As a result, detecting a viral sequence does not automatically indicate the presence of an infectious contaminant. Interpreting results accurately requires sophisticated bioinformatics tools, robust risk assessments, and a thorough understanding of the manufacturing process. A major theme of the article is the importance of early engagement with regulators. Through industry consortia and working groups, many organizations have aligned around a strategy of first developing and validating an NGS method and then seeking regulatory feedback before incorporating it into GMP testing programs. Astellas Pharma followed this approach by engaging the US Food and Drug Administration (US FDA) through a Type D meeting to discuss validation plans and implementation strategies. Industry groups have also promoted harmonization through shared tools such as the First World Health Organization International Reference Panel for Adventitious Virus Detection and the Reference Viral Database (RVDB), helping companies establish more consistent validation and reporting practices. According to Nam and Fradet, regulators are increasingly focused on validating the entire NGS workflow rather than just sequencing performance. Discussions typically cover sample preparation methods, nucleic acid extraction, sequencing strategies, bioinformatics pipelines, reference databases, control strategies, and procedures for investigating positive findings. Regulators also expect companies to explain how they will address detections involving novel or poorly characterized viral sequences that may not be represented in current databases. While regulatory agencies such as the US FDA and Japan's Pharmaceuticals and Medical Devices Agency generally ask similar scientific questions, some differences remain regarding the extent to which NGS can replace traditional assays. Agencies broadly support risk-based, fit-for-purpose validation approaches and recognize the value of NGS within broader viral safety programs. However, complete replacement of conventional adventitious virus testing is still viewed cautiously, with expectations continuing to evolve as more validation data becomes available across the industry. One of the most significant technical challenges is validating a method intended to detect unknown viral threats. Rather than proving detection of a single predefined target, developers must demonstrate that the overall system can reliably identify a broad range of virus types. This requires validation panels representing diverse viral families, including DNA and RNA viruses, enveloped and non-enveloped viruses, and a range of genome structures and sizes. Equally important is maintaining robust, well-curated reference databases capable of supporting sequence classification and highlighting unusual findings that warrant further investigation. The investment required to implement NGS can be substantial. For Astellas Pharma, development and validation of an NGS-based adventitious agent detection platform required approximately 12 to 15 months, including assay optimization, validation activities, and qualification of bioinformatics systems. Yet once established, the benefits can be significant. NGS can consolidate multiple traditional assays into a single workflow, reducing laboratory burden, minimizing cleanroom utilization, and accelerating viral safety assessments. Looking ahead, Nam and Fradet believe the value of NGS extends beyond adventitious virus detection. For genetically engineered cell therapies, sequencing technologies may eventually function as multi-attribute analytical methods capable of addressing several quality and safety questions from a single analysis. Such capabilities could improve process understanding, reduce testing complexity, and support more efficient manufacturing operations. Despite growing momentum, several challenges remain. Organizations must maintain validated software systems, manage large data volumes, implement cybersecurity controls, and continuously update bioinformatics tools and databases. They must also recruit and train staff with expertise spanning molecular biology, sequencing technologies, bioinformatics, and regulatory compliance. Additionally, the industry continues to work toward standardized approaches for investigating and interpreting positive findings, particularly when highly sensitive NGS systems identify low-level signals whose clinical significance is uncertain. As discussions at the 2026 ISPE Annual Meeting & Expo are expected to highlight, next-generation sequencing has the potential to transform viral safety testing in cell and gene therapy manufacturing. By enabling comprehensive detection of known and novel viral threats while reducing testing complexity and sample consumption, NGS is increasingly positioned as a key technology for the future of GMP manufacturing. Success, however, will depend on continued regulatory collaboration, robust validation strategies, and the development of practical frameworks for interpreting the wealth of data these systems generate. About cell & Gene. Cell & Gene delivers in-depth content about cell and gene therapies from experienced professionals in the field. This publication focuses exclusively on this segment of the life sciences industry.

Urology Times
Oct 4th, 2026
Enzalutamide plus salvage radiotherapy associated with improved PFS in high-risk BCR.

Enzalutamide plus salvage radiotherapy associated with improved PFS in high-risk BCR. In RTOG 3506, adding enzalutamide to standard ADT and salvage radiotherapy was associated with 2-year PFS benefit. In men with high-risk biochemical recurrence after radical prostatectomy, adding enzalutamide (Xtandi) to salvage radiotherapy (SRT) and 24 months of a gonadotropin-releasing hormone (GnRH) analog was associated with improved progression-free survival (PFS), according to results from the randomized phase 2 RTOG 3506 (STEEL) trial.[1] "Hormone therapy with salvage radiotherapy is a standard of care. The benefit is not uniform, and this is well known in the field," said lead author, of Cedars-Sinai Medical Center in Los Angeles, California, during the presentation at ASTRO. "In RTOG 9601, 24 months of bicalutamide with SRT did improve overall survival - at 18 years, survival was 53% vs 43%.[2] However, the DADSPORT meta-analysis found that only a small overall survival effect existed, and any survival benefit appeared to be concentrated in men with higher risk disease, such as higher pre-radiotherapy PSAs or higher CAPRA scores.[3] This tells us where it's most likely to matter [is] in men with high-risk features, and this is the population that we focused on in STEEL." STEEL trial design. STEEL (NCT03809000) was a multicenter randomized phase 2 trial led by the RTOG Foundation in partnership with Pfizer and Astellas Pharma, with sites in the US and Canada. Eligible patients had biochemical recurrence after radical prostatectomy, defined as a prostate-specific antigen (PSA) level of 0.2 ng/mL or higher (or 0.1 ng/mL or higher on an ultrasensitive assay), plus at least 1 aggressive feature. These included Gleason score 8 to 10, seminal vesicle invasion, pN1 disease, persistently elevated PSA after prostatectomy (>0.1 ng/mL), or PSA of 0.7 ng/mL or higher. Patients were randomly assigned 1:1 to SRT plus 24 months of a GnRH analog, with or without enzalutamide 160 mg daily. Radiotherapy to both the prostatic fossa (66.6 to 70.2 Gy in 1.8-Gy fractions or 66 to 70 Gy in 2.0-Gy fractions) and the pelvic lymph nodes (45 to 50.4 Gy in 1.8 Gy fractions or 44 to 50 Gy in 2.0-Gy fractions) was mandatory. Para-aortic coverage and nodal boosts were optional. All patients received daily image guidance, and radiotherapy quality was centrally reviewed. "So, the radiotherapy fields were much more contemporary than 9601," said Posadas, referring to the landmark NRG/RTOG 9601 trial. The primary end point was PFS, defined as the first biochemical failure or clinical failure. The protocol originally defined biochemical failure as a detectable PSA of 0.05 ng/mL or higher. Posadas explained that participating sites used assays with different lower limits of detection and that case report forms could not reliably record an undetectable PSA. The investigators therefore analyzed biochemical failure at a threshold of 0.2 ng/mL or higher. Posadas described this analysis as post hoc and said the details will be reported in the full manuscript. Patient population and adherence. The trial enrolled patients from April 2019 through August 2022. In total, 188 patients were randomly assigned: 90 to enzalutamide and 98 to standard ADT. Median age was 64 years, and 11.2% of patients were Black. More Black patients were assigned to the enzalutamide arm than to the standard arm (16.7% vs 6.1%), so race was included in adjusted models. The population was high risk: 45.2% had pT3b disease, 21.8% were pN1, approximately 61% had Gleason score 8 to 10 disease, and 71.8% had more than 1 aggressive feature. Median pre-SRT PSA was 0.605 ng/mL overall and was higher in the enzalutamide arm (0.785 vs 0.565 ng/mL). GnRH analog therapy was completed per protocol by 78% of the enzalutamide arm and 81% of the standard arm. Posadas added, "As you might expect, enzalutamide was a little harder to sustain: 53% of the patients completed treatment per protocol, 18% stopped because of adverse events, and about a third received less than 80% of the planned dose." Efficacy and safety. At a median follow-up of 33.1 months, results showed a PFS benefit favoring the enzalutamide arm (HR, 0.62; 80% CI, 0.42 to 0.91; one-sided P = .052). At 2 years, PFS was 88% with enzalutamide and 79% on the standard arm. After adjustment for aggressive features, race, and age, the HR was 0.54 (80% CI, 0.36 to 0.80; 2-sided P = .04). "The benefit persisted, though nearly half of the patients stopped enzalutamide early," Posadas added. Grade 3 adverse events (AEs) occurred in 30% of patients receiving enzalutamide vs 19% of those receiving standard ADT. Grade 4 AEs occurred in 2% vs 4%, and there were no grade 5 events. Grade 3 or 4 decreased lymphocyte count occurred in 15% vs 5% of patients, and grade 3 or 4 hypertension in 8% vs 5%. Treatment-related cardiac events were rare in both arms. No seizures were reported, although the protocol excluded patients with a history of seizure. "These hypothesis-generating results support a phase 3 trial of intensified AR blockade with salvage radiotherapy," Posadas concluded. "I would suggest that the trial use metastasis-free survival as its end point and have a regimen designed for adherence and capture PSA data with explicit undetectable values." REFERENCES 1. Posadas E, Gay HA, Pugh SL, et al. A Randomized Phase II Study of Enhanced AR Blockade with Enzalutamide In High-Risk Patients with Biochemical Relapse Undergoing Salvage Radiation: Final Results from RTOG 3506 (STEEL). Presented at: 2026 American Society for Radiation Oncology Annual Meeting. September 26 - 30, 2026. Boston, Massachusetts. Abstract 249 2. Lukka PR, Pugh SL, Shipley WU, et al. Long-Term Results of NRG/RTOG 9601, a Randomized Trial of Radiation With or Without Antiandrogens in Patients Receiving Salvage Prostate Bed Radiation Therapy Postprostatectomy. Int J Radiat Oncol Biol Phys. 2025;123(4):990-999. doi:10.1016/j.ijrobp.2025.07.1416 3. Burdett S, Fisher DJ, Tierney JF, et al. Duration of Androgen Suppression with Postoperative Radiotherapy (DADSPORT) for Nonmetastatic Prostate Cancer: A Collaborative Systematic Review and Meta-analysis of Aggregate Data. Eur Urol. 2025;88(3):277-290. doi:10.1016/j.eururo.2025.05.013

Pharmacally
Oct 2nd, 2026
Fezolinetant improves vasomotor Symptoms and Sleep in Phase 4 OPTION-VMS study.

Fezolinetant improves vasomotor Symptoms and Sleep in Phase 4 OPTION-VMS study. Fezolinetant 45 mg improved vasomotor symptoms and sleep measures through week 12 in the Phase 4 OPTION-VMS real-world study. Astellas Pharma U.S. presented preliminary findings from the Phase 4 OPTION-VMS study at the 2026 International Menopause Society (IMS) 20th World Congress on Menopause. The real-world analysis found that women treated with VEOZAH (fezolinetant) 45 mg experienced statistically significant improvements in bothersome vasomotor symptoms (VMS), including hot flashes and night sweats, at week 12, the study's primary endpoint. Improvements were also observed at weeks 4 and 8. VMS frequently disrupt sleep and daily functioning during menopause. Sleep disturbances affect an estimated 40% to 60% of menopausal women, while women with moderate to severe hot flashes are nearly three times more likely to report frequent nighttime awakenings than women without hot flashes. Objective and patient-reported sleep improvements. The preliminary analysis evaluated sleep using both patient-reported outcomes and objective actigraphy data collected through a medical-grade wearable device. Women receiving fezolinetant showed statistically significant improvements in patient-reported sleep disturbance, measured using the PROMIS Sleep Disturbance Short Form 8b, at weeks 4, 8 and 12. Scores moved from the mild sleep disturbance range at baseline into the no-sleep-disturbance range by week 4, with improvements maintained through week 12. Objective sleep measures also improved significantly at all three time points. These included wakefulness after sleep onset (WASO), sleep efficiency, sleep latency and nighttime awakenings. By week 12, women treated with fezolinetant experienced a mean reduction of 2.6 nighttime awakenings from baseline. The improvement in VMS exceeded the prespecified minimal clinically important difference, supporting the clinical relevance of the observed symptom reduction. The study was not designed to compare the effectiveness of fezolinetant with other non-hormonal treatment groups. OPTION-VMS evaluates real-world treatment outcomes. OPTION-VMS (NCT06049797) is a Phase 4, longitudinal observational study involving women aged 40 to 75 years with menopausal hot flashes and night sweats who received non-hormonal therapy in routine clinical practice. The study includes women prescribed fezolinetant, SSRIs/SNRIs and other non-hormonal therapies, including gabapentin and oxybutynin. The primary endpoint assessed changes in bothersome VMS at week 12 using the Menopause-Specific Quality of Life (MENQOL) VMS domain score. Additional outcomes include sleep quality, menopause-related quality of life, sexual health, mood, work productivity and safety. No new safety signals were identified in the preliminary fezolinetant analysis. Two participants experienced mild, non-serious elevations in liver laboratory tests; neither case resulted in treatment or study discontinuation. Fezolinetant targets the KNDy neuron pathway. Fezolinetant is a selective neurokinin 3 (NK3) receptor antagonist that blocks neurokinin B signaling within the hypothalamic kisspeptin/neurokinin/dynorphin (KNDy) neuronal pathway. This pathway contributes to thermoregulatory control during menopause. By reducing excessive KNDy neuron signaling, fezolinetant modulates the brain's temperature-regulation system and reduces the frequency and severity of moderate to severe VMS. Additional real-world data expected. The OPTION-VMS findings add to the real-world evidence for fezolinetant, particularly regarding sleep outcomes. Astellas is also presenting interim findings from the ongoing GRACE study in Germany and ADELE-AU study in Australia at IMS 2026. GRACE (NCT07455812) is a 24-week observational study evaluating effectiveness, safety, symptom improvement, quality of life, sleep disturbance and treatment satisfaction among women receiving fezolinetant in Germany. ADELE-AU is evaluating real-world sleep outcomes among Australian women treated with fezolinetant for moderate to severe VMS. These studies are expanding the real-world evidence base for fezolinetant, with sleep outcomes providing additional insight into treatment effects beyond control of menopausal vasomotor symptoms. Reference. New Preliminary Real-World VEOZAH(TM)(fezolinetant) Data Highlights Improvements in Menopause-Related Symptoms and Sleep Outcomes, Astellas, 02 October 2026 A Study Following Women in Menopause Treated with a Non-hormonal Therapy for Hot Flashes and Night Sweats (OPTION-VMS), ClinicalTrials.gov ID NCT06049797 About the Writer Creola Gonsalves (Linkedin) is an M.S. Biotechnology postgraduate with a strong interest in clinical research, evidence interpretation, and healthcare writing, with a focus on translating life-science knowledge into meaningful real-world insights. She is trained in Good Clinical Practice (GCP), clinical research principles, and critical interpretation of randomized clinical trials, with certifications from NIH and Stanford University. Her research background in biotechnological applications and microbial research strengthens her ability to understand scientific evidence and develop clear, accurate, and research-driven healthcare content.

IDA Ireland
Sep 14th, 2026
Astellas strengthens commitment to Ireland with expanded investment in Tralee biopharmaceutical facility

Astellas strengthens commitment to Ireland with expanded investment in Tralee biopharmaceutical facility. 14/09/2026 Ireland September 14th: Astellas Ireland Co. Ltd today announced an expansion of its biopharmaceutical manufacturing facility at the Kerry Technology Park in Tralee. The investment will support the installation of a second aseptic filling line and associated manufacturing infrastructure, representing the next phase of development at the site, building upon the successful foundation established with the site's groundbreaking in March 2024. The project will double drug product manufacturing capacity at the Tralee facility, creating additional highly skilled roles across engineering, production, quality, logistics and support functions by 2029. To explore career opportunities with Astellas, please visit Tralee - Astellas Jobs. This follows the company's previously announced €330 million investment in a new state-of-the-art biopharmaceutical facility and second Kerry facility in 2023. The new Kerry facility is scheduled to officially open the doors in early 2027. This project is supported by the Irish Government through IDA Ireland. Minister For Children, Disability and Equality Norma Foley TD said: "Astellas has been an extraordinary success story for County Kerry. Building on the strong track record and excellence of the Killorglin facility, this new development in Tralee is a gamechanger for our capital town and the entire South West region. The doubling of drug product manufacturing capacity in the Tralee facility and the additional employment it brings is a very significant uplift to the local economy and community. We are incredibly proud in Kerry to be home to two state-of-the-art Astellas facilities. I'd like to thank Astellas Ireland for their longstanding and valued commitment to County Kerry and also acknowledge the work of IDA Ireland, Kerry County Council and all state agencies involved." Minister For Enterprise Tourism and Employment Peter Burke TD said: "Astellas' decision to further expand its Tralee facility is a strong endorsement of Kerry's growing role in Ireland's life sciences ecosystem. This investment demonstrates how regional locations can successfully attract and support complex, high-value manufacturing operations. As Astellas continues to scale its presence in Tralee, this expansion will create additional highly skilled career opportunities and further strengthen the South-West's reputation as a location of choice for international investment and advanced manufacturing. I wish Astellas success in this next growth phase." The Tralee facility will manufacture medicines for global markets and is designed to support additional products from Astellas' development pipeline as they progress towards commercialisation. Tetsuya Kawasko-San, Global Head of Pharma Manufacturing, President of Astellas Ireland Co LTD said: "Astellas has a proud and long-established presence in Ireland, with our operations supporting the reliable supply of medicines to patients around the world. The continued development of our Tralee facility reflects our confidence in Ireland, in the region and in the talented people who will bring this state-of-the-art facility to life. This expansion is a planned continuation of our original investment in Tralee. It enables us to build additional capability into the facility in a phased and disciplined way, responding to an evolving portfolio and patient needs while making the best use of the infrastructure already being developed. We greatly value the continued support of IDA Ireland and our local partners, and we look forward to building on that partnership as Tralee becomes an important part of Astellas' global manufacturing network." Mary Buckley, Executive Director, IDA Ireland said: "Astellas' decision to expand its new biopharmaceutical manufacturing facility in Tralee is a strong endorsement of Ireland's position as a leading location for advanced life sciences and of the talent and partnership available in the South West region. Building on the company's €330 million commitment to the site, this additional investment will create further highly skilled roles in Kerry and strengthen Astellas' capacity to supply medicines for global markets. IDA Ireland is proud to support Astellas as it continues to grow its significant presence here and contribute to the development of Ireland's world-class biopharmaceutical ecosystem."

PR Newswire
Aug 31st, 2026
Astellas enters voluntary agreement with U.S. government supporting affordable access to medicines.

Astellas enters voluntary agreement with U.S. government supporting affordable access to medicines. Aug 31, 2026, 18:00 ET - Agreement supports commitment to patient access, affordability and innovation - TOKYO, Aug. 31, 2026 /PRNewswire/ - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has reached an agreement with the U.S. government that reflects our commitment to patient access, affordability and innovation, while reinforcing Astellas' longstanding commitment to the U.S. healthcare system. Under the agreement, Astellas will take the following actions: * Lower the prices of medicines in Medicaid and establish pricing for future medicines aligned with other developed nations that reflect international market conditions, innovation, and patient value. * Further the resilience of the supply chain for important medicines by donating 25 kg of tacrolimus active pharmaceutical ingredient (API), the standard used to prevent solid organ transplant rejection, to the U.S. Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). Additional terms of the agreement are not being disclosed. This agreement reflects our longstanding commitment to improving access for patients while continuing to invest in the research and development of innovative medicines. We believe patients benefit most when affordability and innovation advance together, and we remain committed to working collaboratively with governments and healthcare stakeholders around the world to achieve both objectives for patients with serious unmet medical needs. With U.S. headquarters in Northbrook, Ill., Astellas has a significant research, manufacturing, and economic footprint in the U.S. that supports patients, jobs and communities spanning from Massachusetts to California. Within the past ten years, Astellas has opened two new cutting-edge manufacturing facilities in the U.S., including a cell therapy manufacturing facility in Westborough, Mass., and a gene therapy manufacturing facility in Sanford, North Carolina. In 2024, Astellas also opened two new research centers - our West Coast Innovation Center in South San Francisco and the Astellas Life Sciences Center in Cambridge, Mass. About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. SOURCE Astellas Pharma Inc.