BAYER AG

The Global Clinical Trials Connect 2025 conference will discuss futuristic advancements in clinical trials, focusing on innovative strategies, new technologies, and quality collaborations to address increased complexity. Topics include patient recruitment, site selection, data integration, outsourcing, and risk-based monitoring. The event targets senior-level professionals from pharmaceutical, bio-tech, and CRO companies, offering networking and case study presentations.

FDA accepted Bayer's sNDA for darolutamide (Nubeqa) plus ADT for metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide plus ADT significantly extended rPFS vs placebo plus ADT in the ARANOTE trial. Bayer seeks EU approval and aims to expand Nubeqa's indication to include mHSPC with and without chemotherapy.

Huntington's disease treatments face challenges due to rarity and trial failures, but recent milestones like Wave's WVE-003, Roche-Ionis' tominersen, uniQure's AMT-130, and PTC Therapeutics' PTC518 offer hope. Prilenia's pridopidine is under EMA review, while Annexon's ANX005 and Sage's dalzanemdor faced setbacks. Despite these, cautious optimism remains for effective treatments.

Top pharmaceutical companies like Pfizer, Roche, Johnson & Johnson, Novartis, Merck, AstraZeneca, Sanofi, GSK, AbbVie, and Bayer lead in innovation, focusing on areas such as mRNA vaccines, cancer treatments, immunology, and gene therapy, shaping the future of healthcare through R&D investments and strategic pivots.

Recursion and Exscientia complete AI-based drug development merger, creating a trans-Atlantic powerhouse with over 30 clinical and preclinical programs. The combined company, headquartered in Salt Lake City, focuses on oncology and rare diseases, with REC-617 (CDK7 inhibitor) and REC-994 (CCM treatment) as key candidates. The merger aims to generate $100 million in annual savings through operational synergies, including job cuts, and expects to receive over $20 billion in additional milestone payments from partnerships with Roche, Sanofi, Bayer, and others.

AI-powered ECG tech and patient-centered solutions are revolutionizing clinical trials, enhancing cardiac safety, data integrity, and trial efficiency. This webcast explores how these innovations align with FDA guidance and improve clinical research practices.

Agricultural biotechnology for transgenic crops market size was $34.24B in 2023, expected to grow to $68.8B by 2032 with a CAGR of 8.07%. Key players include Bayer AG, BASF SE, Syngenta AG, Corteva Agriscience, and Dow AgroSciences. Market segments include type, technology, application, and crop type, with North America leading, Asia-Pacific fastest-growing, and Europe gradually accepting GM technology.

Astellas' request to update Izervay's prescribing info rejected by FDA; Jupiter Bioventures, co-founded by Norman Sharpless and Nathaniel David, launches with $70M to create biotech startups; Bayer pays Cytokinetics $53M for aficamten licensing in Japan; Neurogene continues Rett syndrome gene therapy trial at lowest dose after side effects; Cybin's stock dips despite positive Phase 2 data for CYB003; Novartis licenses radiopharmaceutical from Ratio Therapeutics, targeting SSTR2 protein.

Fanaroff: Research grants from American Heart Association and National Institutes of Health; consulting fees from Abbott Laboratories. Vora: Consulting fees from Medtronic. Mehran: Institutional research grants from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis, OrbusNeich; consulting fees from Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Roivant Sciences Inc, Sanofi; consulting (no fees) for Regeneron Pharmaceuticals Inc; institutional consulting fees from Abbott Vascular, Spectranetics/Phillips/Volcano Corporation, Bristol Myers Squibb, Novartis, Watermark Research; Executive committee member for Janssen Pharmaceuticals and Bristol Myers Squibb; <1% equity in Claret Medical and Elixir Medical. Granger: Research grants from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Armetheon, AstraZeneca, US Food and Drug Administration, GlaxoSmithKline, The Medicines Company, Medtronic Foundation, Medtronic Inc, Novartis; consulting fees from Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Abbvie, Armetheon, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, The Medicines Company, National Institutes of Health, Novartis, Sirtex, Verseon, Apple, Medscape, LLC, Merck, Novo Nordisk, Roche Diagnostics, Rho Pharmaceuticals. Goodman: Research grant support and/or speaker/consulting honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Eli Lilly, Esperion, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Novo Nordisk A/C, Pfizer, Regeneron, Sanofi, Servier, Tenax Therapeutics, Heart and Stroke Foundation of Ontario/University of Toronto, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Duke Clinical Research Institute, PERFUSE. Aronson: Employee of Bristol Myers Squibb. Windecker: Institutional research and educational grants from Abbott, Amgen, Bayer, BMS, CSL Behring, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Polares, Sinomed. Alexander: Research grants from Bristol Myers Squibb, Boehringer Ingelheim, AstraZeneca, CryoLife, CSL Behring, US Food and Drug Administration, National Institutes of Health, Sanofi, VoluMetrix; consulting fees from Pfizer, Bristol Myers Squibb, AbbVie Pharmaceuticals, CSL Behring, Novo Nordisk, Portola Pharmaceuticals, Quantum Genomics, Teikoku Pharmaceuticals, VA Cooperative Studies, Zafgen. Lopes: Research grants from Bristol Myers Squibb, Pfizer, Amgen, Inc, GlaxoSmithKline, Medtronic PLC, Sanofi Aventis; consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer AG. The other authors report no conflicts.