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AI-driven Advancements in Life Sciences
The momentum behind AI-driven advancements in life sciences has never been stronger, and this trend was spotlighted in Everest Group’s new 2025 PEAK Matrix® report, “Life Sciences AI and Analytics Services for Commercial PEAK Matrix® Assessment 2025.” Trinity Life Sciences is honored to be recognized as a Leader in this comprehensive assessment, a distinction rooted…
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Mapping the Unknown: Measuring Cell and Gene Therapy Adoption Using Real-World Evidence
It’s been 10 years since the first pediatric patient was treated with chimeric antigen receptor T-cell (CAR-T) therapy for her acute lymphoblastic leukemia. At the time, the approach to engineer immune cells was a novel, ground-breaking concept. In the subsequent decade,...
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The Humira Case: Exploring the Blockbuster Ahead of United States Biosimilar Launch
Up to nine biosimilar versions of Humira (adalimumab) are expected to launch in 2023 in the United States, following settlements between AbbVie and their respective manufacturers. In contrast, biosimilar versions of adalimumab have been available in most countries [...]
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France Pilots Opportunity to Increase Speed to Reimbursement for Select Innovative Products
French president Emmanuel Macron announced a two-year trial that will allow pharmaceutical products that receive an ‘Amélioration du Service Médical Rendu’ (ASMR) rating of IV or better to get reimbursement [...]
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How Effective is ANVISA’s Rare Diseases Expedited Approval Pathway [RDC 205]?
An analysis was conducted of all the orphan therapies registered by the FDA and ANVISA before and after 2018 to effectively evaluate approval times once the RDC 205 pathway was implemented. The main takeaways from the analysis can be found below [...]
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EU Adopts Regulation on Pan-European Health Technology Assessment
Pan-European HTA will enter into force in January 2022 and finally become active in 2025. This comes almost four years after the European Commission’s original proposal, and at a time where urgency for European HTA processes is growing [...]
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Key Changes to Health Technology Assessments (HTAs) in the UK
The National Institute for Health and Care Excellence (NICE) will mark the start of 2022 by implementing changes to health technology assessments (HTAs), demonstrating adaptability of regulatory bodies as medical technologies continue to evolve. The final HTA changes aim to provide...
