All Legal & Compliance articles
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ArticleNavigating IND delays: strategic options for early-phase biotech development
As IND timelines lengthen, early-stage biotechs face growing uncertainty in early clinical planning. This article explores how sponsors are increasingly diversifying their development strategies and why New Zealand represents an attractive option.
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NewsNew paper warns against phasing out animal testing too quickly
A push by the US Food and Drug Administration to phase out animal testing in drug development could improve efficiency and reduce animal suffering, but experts warn that moving too quickly may pose risks to patient safety.
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NewsLife sciences face ‘scientific content crisis’ in AI adoption
A new survey by the Pistoia Alliance reveals a growing ‘scientific content crisis’ in life sciences, showing that incomplete data and weak governance are limiting the accuracy and adoption of AI in research and development.
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NewsRare disease drugs get boost from new NICE guidelines
NICE has raised the cost-effectiveness thresholds for ultra-rare disease drugs under its Highly Specialised Technology programme – a move welcomed by patient advocates and biotech leaders.
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NewsEurofins Assurance gains ISO/IEC 17065:2012 GMP accreditation
The Eurofins Assurance network has secured ISO/IEC 17065:2012 accreditation from ANAB for its Good Manufacturing Practices (GMP) certification programme.
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ArticleMaking sense of AI: bias, trust and transparency in pharma R&D
AI is increasingly used in drug discovery, but hidden bias and ‘black box’ models threaten trust and transparency. This article explores how explainable AI can turn opaque predictions into clear, accountable insights.
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ArticlePlasmids: Tackling Supply Chain and Manufacturing Challenges
Gene therapy’s progress depends on reliable supply chains and efficient manufacturing. In this episode, we explore the challenges and strategies involved in plasmid production - an essential component in advancing life-changing therapies.
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NewsEurofins expands to China to strengthen local expertise
Eurofins Healthcare Assurance is expanding into China to better serve key industries with local expertise. This move strengthens their commitment to quality assurance and regulatory services on a global scale.
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NewsBrain organoids: essential ethical investigation
The potential for brain organoids to develop consciousness is a key issue in neuroscience, which has prompted new ethical considerations.
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NewsHPV vaccine cost reimbursement could hinder vaccine access
Bare minimum reimbursement rates could be why some clinics may be struggling to offer HPV vaccination in the US.
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NewsAre tiny brain organoids legally a person?
Japanese researchers debate if human brain organoids that are cultivated from stem cells and serve as a model of human brain development, can be legally considered a person.