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US and European Regulators Set Principles for Responsible AI Use in Drug Development
US and European medicines regulators have jointly issued a set of guiding principles to support the safe, effective and responsible use of artificial intelligence (AI) in drug development, marking a significant step toward regulatory alignment on emerging technologies.
UK Sees Surge in Clinical Trials as MHRA Unveils Faster Approval Pathways
UK is boosting its global clinical trials appeal through rising trial activity and new fast-track MHRA regulations, enabling quicker approvals, earlier patient access and increased investment.
Bayer to Enter Molecular Imaging, Acquires Pan-Amyloid Radiotracers from Attralus
By acquiring AT-01 and AT-05 from Attralus, Bayer strengthens its molecular imaging and cardiovascular precision medicine portfolio, targeting earlier and more accurate diagnosis of amyloidosis.
First Patient Dosed in Phase III Tropian-Lung17 Trial of Datroway in Advanced NSCLC
The global Phase III study evaluates Datroway versus docetaxel in Trop2 NMR-positive advanced nonsquamous NSCLC patients previously treated with immunotherapy and platinum chemotherapy.
Nvidia and Eli Lilly Commit USD 1 Billion to AI-Driven Drug Discovery Lab
Nvidia and Eli Lilly and Company have announced plans to invest up to USD 1 billion over five years to establish a joint AI research laboratory focused on transforming drug discovery and pharmaceutical R&D.
Bayer Targets Return to Mid-Single-Digit Pharma Growth by 2027
Addressing investors at a major healthcare conference, Stefan Oelrich, head of Bayer’s pharmaceuticals business, said the company expects 2026 to be the final year significantly affected by the loss of exclusivity on its blockbuster anticoagulant Xarelto. From 2027 onward, Bayer anticipates a recovery driven by newer medicines and pipeline progress.
WuXi Biologics Introduces PatroLab to Enable Real-Time, Predictive Biomanufacturing
WuXi Biologics, a global contract research, development and manufacturing organization (CRDMO), has launched PatroLab, a next-generation digital twin platform aimed at reshaping bioprocess development and biologics manufacturing.
Alphatec Signs Strategic US Commercial Deal with Theradaptive, Backs Series B Expansion
Alphatec Holdings Inc (ATEC), a spine-focused medical technology company, and Theradaptive Inc, a clinical-stage regenerative medicine innovator, have entered into a definitive strategic partnership to advance next-generation biologic solutions for spine surgery.
FDA Publishes Guidance on Modern Statistical Methods for Clinical Research
The FDA guidance provides a framework for applying Bayesian analyses in clinical research, enabling data-driven assessments of safety and efficacy using both current and prior evidence.
Enspire DBS Therapy Raises USD 10.3M Series B1 to Advance Post-Stroke Neuromodulation Trial
The funding led by Genesys Capital will support continued enrollment in Enspire’s pivotal restore clinical trial evaluating deep brain stimulation combined with rehabilitation for stroke recovery.
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