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The AI model that is changing clinical trial design

Drug Target Review

Regulatory backing The pharmaceutical industry is often open to innovation in principle, but the demands of regulatory compliance can slow the adoption of emerging technologies – particularly those that challenge conventional trial design. Unlearn’s early collaboration with regulators has helped it navigate this space effectively.

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CMC Content for Global Clinical Development of Pharmaceuticals

The Premier Consulting Blog

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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Novartis Acquires Regulus Therapeutics, Expanding its RNA-Based Drug Pipeline

The Pharma Data

Novartis Finalizes Acquisition of Regulus Therapeutics, Strengthening Its Renal Disease Portfolio with Promising ADPKD Therapy Novartis AG, a leading global pharmaceutical company, has officially completed its acquisition of Regulus Therapeutics Inc. , a biotechnology firm known for its expertise in microRNA-targeting therapies.

RNA 52
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From siloed data to breakthroughs: multimodal AI in drug discovery

Drug Target Review

By integrating diverse data sources and leveraging AI , the industry hopes to overcome the challenges of complex drug development and accelerate the delivery of effective treatments to patients. About the authors Remco Jan Geukes Foppen , PhD, is an AI and life sciences expert specialising in the pharmaceutical sector.

Drugs 64
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Navigating the Challenges and Opportunities of the PICO Framework in the New EU HTA Regulation

PPD

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

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BioMarin Completes Acquisition of Inozyme Pharma

The Pharma Data

BioMarin Finalizes Acquisition of Inozyme Pharma, Strengthening Rare Disease Portfolio with INZ-701 BioMarin Pharmaceutical Inc. INZ-701 is designed to replace deficient ENPP1 enzyme activity, with the aim of restoring normal regulation of mineralization processes in the body.