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Life Science & Pharma News
The latest pharmaceutical, biotechnology, MedTech, and healthcare news and analysis from Ireland, the EU, and globally.
224
Articles
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IE
Ireland first
Regulatory Affairs
Data Integrity and Quality Oversight: Analyzing the FDA Warning Letter for Sanofi's Waterford Site
Following a January 2026 inspection, the FDA has issued a formal warning letter to Genzyme Ireland Limited in Waterford, citing data integrity concerns, uncontrolled checklists, and quality unit oversight gaps in the manufacturing of Thymoglobulin and Altuviiio.
Regulatory Affairs
A Global Milestone for Wellness: Chanelle McCoy Health Secures Historic Dual SFDA and European Novel Food Regulatory Approvals
In a landmark world-first, Irish-founded Chanelle McCoy Health has received official regulatory approvals from the Saudi Food and Drug Authority and confirmation of safety under EU Novel Food guidelines for its Pureis® Ultra Pure CBD range.
Regulatory Affairs
The Digital and Regulatory Frontier: Top 10 Technical and GMP Trends Shaping Pharma in 2026
A comprehensive technical report detailing the top 10 trends in Good Manufacturing Practice (GMP), sterile manufacturing, GAMP 5, Quality 4.0, and continuous manufacturing currently reshaping the global pharmaceutical landscape.
Industry
Funding the Future: Inside the €75k Women TechEU and £10M Createch Grants for Startups and SMEs
An in-depth analysis of two newly opened funding opportunities-Women TechEU and Innovate UK's Next Wave Createch-designed to support early-stage deep tech and creative technology innovators across Europe and the UK.
Regulatory Affairs
FDA Fires Warning Shot at Sanofi's Irish Plant Over Data Cover-Up and Altuviiio Quality Failings
The FDA has issued a formal warning letter to Sanofi's Waterford facility, Genzyme Ireland Limited, citing data integrity breaches, discarded quality records, and botched deviation investigations in the production of haemophilia drug Altuviiio and transplant therapy Thymoglobulin.
Pharmaceutical
Cold Chain Management and Good Distribution Practice (GDP) for Biologics and Vaccines
An academic analysis of temperature-sensitive supply chains, GDP compliance, distribution monitoring, and shipping deviation management.
Regulatory Affairs
Understanding the Common Technical Document (CTD) Structure for Global Regulatory Submissions
An explanation of the 5 modules of the ICH Common Technical Document (CTD) format required for global drug marketing authorization applications.
Pharmaceutical
Media Fill Validation: Guidelines for Simulating Aseptic Liquid Processing Operations
A review of aseptic process simulation (APS), growth media selection, incubation parameters, and contamination limits in media fill validation.
Regulatory Affairs
Navigating Global Price Controls: How the US Inflation Reduction Act and Evolving EU Policies Shape R&D in 2026
As global health systems enforce tighter pricing controls under the US IRA and EU health technology updates, biopharma majors are restructuring their R&D portfolios to manage clinical risks.
Pharmaceutical
An Introduction to Lyophilization (Freeze-Drying) Technology and Cycle Development in Biopharma
An academic analysis of the freeze-drying process, sublimation phases, critical chamber controls, and lyophilized formulation parameters.
Regulatory Affairs
Data Integrity in the Pharmaceutical Quality Control Laboratory: ALCOA+ Principles Explained
An educational review of data integrity requirements in pharma QC, covering ALCOA+ principles, audit trails, and data security.
Regulatory Affairs
Out of Specification (OOS) Investigations: Step-by-Step Root Cause Analysis and CAPA Guidelines
A structured tutorial on handling quality control laboratory OOS results, conducting Phase I/II investigations, and implementing corrective actions.