New European Regulations Could Hinder Rare Disease Treatments, Pharma Industry Raises Concerns Over Stricter Clinical Trial Rules
Portfolio Pulse from Vandana Singh
New EU regulations imposing stricter guidelines on medical trials, particularly limiting single-arm trials, could hinder the development of treatments for rare diseases. Nearly 40 organizations have urged revisions, emphasizing the importance of single-arm trials for rare disease research. Critics argue the guidelines could stifle innovation in rare disease treatment.
August 13, 2024 | 5:58 pm
News sentiment analysis
Sort by:
Descending
NEGATIVE IMPACT
AstraZeneca may face challenges in developing rare disease treatments due to new EU regulations limiting single-arm trials, which are crucial for such research.
AstraZeneca is involved in developing treatments for rare diseases, and the new EU regulations limiting single-arm trials could hinder their research and development efforts.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80
NEGATIVE IMPACT
GlaxoSmithKline may encounter difficulties in advancing rare disease therapies due to new EU regulations that restrict single-arm trials, essential for such treatments.
GlaxoSmithKline's efforts in rare disease treatment development could be impacted by the new EU regulations that limit the use of single-arm trials, which are vital for such research.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80