Commercialising drugs in Europe: Lean models for first-time launchers
In 2025, 193 innovative drugs received approval in Europe, including 133 new molecular entities (NMEs). Over half – 56% -…
All articles by Miranda Mclaren
Miranda Mclaren
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Lyophilisation is growing in pharma, but technical challenges persist
Lyophilisation, or freeze drying, is the process in which a liquid drug is converted into a stable powder via sublimation,…
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China-ready by design: Leveraging NMPA’s new 30‑working day IND pathway
Over the last decade, China has become a key destination for oncology clinical trials, with Chinese sites increasingly incorporated within…
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Why manual aseptic filling often provides faster start dates than automated lines
A Phase 1 start date may be tied to investor milestones. A rare disease therapy may represent a small patient…
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Biomarkers in Nephrology Research: From Exploratory to Decision-Making Tools
While strategic use of biomarkers in clinical trials has traditionally been associated with oncology, the potential for growth across other…
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Annex 1 sterilisation: Why pharma packaging strategy is changing
The revised EU GMP Annex 1 has ushered in a new phase for sterile manufacturing. Published in 2022, with most…
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Early Biomarkers as Predictors of Nephrology Trial Trajectory
Chronic kidney disease (CKD) and other nephrology conditions are a major global health challenge. With rising prevalence and persistent unmet…
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The evolution of the ADC market – and what it means for commercial packaging
The ADC market The first antibody drug conjugate (ADC) was approved in 2000 by pairing a cytotoxic chemotherapy agent with…
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Complementing DepMap: Expanding the toolkit for oncology target discovery and de-risking
With cancer responsible for one in six deaths around the world, precision medicines based on the root cause of the…
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Designing vial systems to meet the demands of complex biologics
Large molecule medicines are transforming treatment paradigms for many chronic and debilitating diseases, targeting previously “undruggable” pathways and marking a…