ASTELLAS PHARMA EUROPE LTD.

The FDA added a boxed warning for rare but serious liver injury to fezolinetant (Veozah) labeling, emphasizing hepatotoxicity and increased LFT testing. A postmarketing report detailed a patient's severe hepatic injury, resolved after treatment cessation. Fezolinetant, approved in May 2023 as the first non-hormonal VMS treatment, restores neurokinin B balance disrupted by menopause. The updated prescribing info includes monthly LFT testing for 2 months post-initiation, then at 3, 6, and 9 months, with immediate discontinuation upon liver injury symptoms.

Asia Deal Watch: Kaken acquires Aadi subsidiary and cancer drug Fyarro. Other deals include Hangzhou DAC/Aadi, Astellas/Sangamo, Kyorin/Bayer, Eisai/Newron, Lupin/Boehringer Ingelheim, Asahi Kasei/Chiome.

Focke Ziemssen, Michelle Sylvanowicz, Winfried M. Amoaku, Tariq Aslam, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian, Jean-François Korobelnik, Xiaofeng Lin, Anat Loewenstein, Paul Mitchell, Moira Murphy, David R. Owens, Nick Parker, Ian Pearce, Francisco J. Rodríguez, Jude Stern, S. James Talks, David T. Wong, Tien Yin Wong, and Jane Barratt disclose various financial interests including travel grants, personal fees, advisory board memberships, speaker fees, research sponsorship, and consulting roles with companies such as Allergan, AbbVie, Alimera, Bayer Healthcare, Biogen, Boehringer Ingelheim, Janssen, Novartis, Novo Nordisk, Merck, Regeneron, Roche, Sanofi, and others.

2024 saw significant progress in digital health, particularly in AI adoption, as healthcare navigated economic shifts and technological advancements. Moving into 2025, AI will continue to accelerate in clinical workflows but face added scrutiny for quality and safety. Misinformation will persist, challenging public trust, while digital health companies can help rebuild it through transparency and education. Healthcare M&A is expected to increase with reduced FTC scrutiny, and pharma pricing and PBMs will remain under pressure. Medicaid will see a partisan split, with red states potentially reducing expansion and blue states increasing coverage. The dementia crisis will be addressed through digital innovations like the GUIDE program, and biopharma will focus more on consumer engagement and retention. Overall, 2025 is poised for continued innovation in digital health despite regulatory uncertainties.

Clinical research professionals are increasingly using AI for drug discovery, data analysis, and patient care, such as AI tools for stroke diagnosis and treatment, machine learning models for trial data interpretation, and AI-driven drug development processes.

The ARANOTE trial demonstrated that darolutamide plus androgen-deprivation therapy (ADT) without chemotherapy improved radiological progression-free survival by 46% in metastatic hormone-sensitive prostate cancer (mHSPC) patients compared to placebo plus ADT (HR 0.54, 95% CI 0.41-0.71, P<0.0001). The combination showed consistent benefits across subgroups, including high- and low-volume disease, and improved overall survival (OS) rates at 24 months (79.8% vs. 75.5%). Darolutamide also exhibited better tolerability with lower rates of fatigue and adverse event-related discontinuation compared to placebo.

Astellas' Vyloy, a first-in-class gastric cancer treatment, faced complex development challenges, including manufacturing setbacks and the need for a companion diagnostic from Roche. Dr. Tadaaki Taniguchi, Astellas' chief medical officer, highlights the importance of biomarker identification, diagnostic development, and physician education in precision medicine. The approval of Vyloy alongside Roche's diagnostic underscores the collaborative efforts required in oncology precision medicine. Astellas aims to expand Vyloy's use to pancreatic cancer and continues to explore new treatment modalities in oncology.

EFPIA highlights EU's roadmap for precision oncology to address rising cancer burden, despite forecasted mortality rate declines. Stakeholder roundtable in Brussels aims to improve personalized cancer treatment. EU initiatives, including AI-powered cancer care and the DigiONE pilot, aim to advance precision medicine. A gold-standard cancer data management system is necessary for innovative precision medicine access, emphasizing standardized data formats, robust privacy, and professional education.

Astellas Pharma US, Inc. launches 'Cooler Moments' with Dr. Jen Ashton to educate and empower women in midlife to speak up about menopausal hot flashes and night sweats, offering nonhormonal treatment options like VEOZAH.

Astellas Pharma US, Inc. launches 'Cooler Moments' with Dr. Jen Ashton to educate and empower women in midlife about menopausal hot flashes and night sweats, promoting discussion and treatment options, including the hormone-free VEOZAH.