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EMA Invites Comments on Good Biomarker Practice
The European Medicines Agency (EMA) has released a consultation on good genomics biomarker practices.
The European Medicines Agency (EMA) has released a consultation on good genomics biomarker practices.
The outcome of the consultation will inform a guideline, which will set criteria to underpin the generation of robust clinical genomic datasets throughout a medicine’s lifecycle, the choice of genomic techniques and biomarkers, the impact on the relevant study design, and the appropriate level of analysis and reporting of genomic data. The goal is to enhance transparency, consistency, reproducibility and cross-validation between genomic-driven studies.
Comments on the paper are invited until October 31, 2014 and should be sent to pgwpsecretariat@ema.europa.eu.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
