Articles

NICE Technology Appraisals 2026: Impact on EU Pharmaceutical Market Access

NICE Technology Appraisals 2026 will significantly reshape the landscape for cancer drug access in the EU, impacting market dynamics and patient outcomes.

MHRA Post-Brexit Drug Approval: Key Divergences from EMA in Oncology

This article examines the MHRA's post-Brexit drug approval framework for oncology, focusing on significant divergences from the EMA's processes.

EU Pharmaceutical Legislation Reform: Impact on Generic and Biosimilar Markets 2026-27

The upcoming EU Pharmaceutical Legislation Reform will significantly reshape the landscape for generic and biosimilar drugs, influencing market dynamics through 2026-27.

EMA Accelerated Assessment Program: Impact on Oncology Drug Approval Timelines

The EMA's Accelerated Assessment Program significantly shortens oncology drug approval timelines, improving patient access to vital treatments such as Keytruda.

EMA Conditional Approval Pathway: Linvoseltamab and Oncology Access in EU

This article delves into the EMA's Conditional Approval Pathway, focusing on Linvoseltamab and its impact on oncology access across the European Union.

CAR-T Therapies Cost-Effectiveness: EU HTA Bodies' Divergent Assessments

This article examines the varying assessments of CAR-T therapies' cost-effectiveness by EU HTA bodies, highlighting implications for cancer treatment.

MHRA post-Brexit regulatory pathways: What You Need to Know

Explore the essential MHRA post-Brexit regulatory pathways for drug approval, ensuring compliance and understanding for pharmaceutical professionals.

Real-World Evidence EU Drug Development: EMA's Hybrid Trial Framework

The EMA's Hybrid Trial Framework revolutionizes drug development by integrating real-world evidence, improving outcomes for patients with chronic conditions.

EU Pharmaceutical Legislation Reform: Impact on Orphan Drug Development & Market Exclusivity

The EU's pharmaceutical legislation reform aims to enhance orphan drug development and market exclusivity, significantly influencing treatments for rare diseases.

EU HTA Radioligand Therapy Assessment: Price, Access & Challenges

This article delves into the EU HTA's evaluation of radioligand therapy for prostate cancer, highlighting pricing, access issues, and the challenges in the healthcare landscape.

CHMP Positive Opinions Diabetes Drugs: What You Need to Know Q3 2026

In Q3 2026, the CHMP issued positive opinions for key diabetes drugs, including Ozempic and Jardiance, highlighting advancements in diabetes management.

EMA Decision on Biosimilar Pricing: Key Insights for Oncology Market

The EMA's recent decision on biosimilar pricing offers crucial insights for the oncology market, influencing drug accessibility and treatment options.

PRAC Guidelines Liver Injury: What You Need to Know

Learn about the latest PRAC guidelines on liver injury, focusing on drugs like Paracetamol, to ensure safe and effective pain management.

AI Drug Discovery EU: Accelerating Rare Disease Therapies via COMP & EMA

Discover how AI technology is transforming drug discovery for rare diseases, enhancing the development of therapies under the EU's COMP and EMA frameworks.

Real-World Evidence in EU: Leveraging EHRs for Regulatory Decisions

This article delves into the role of real-world evidence from electronic health records in shaping regulatory decisions for drugs in the EU, improving healthcare delivery.