Hurdles to Harmonization
Don’t Sleep On The EU! Hurdles to Harmonization A Strategic Guide for Biotech and Pharma Facing FDA Setbacks in Rare Disease Therapy Development Experiencing a setback with the FDA in your rare disease therapy development can feel like a significant hurdle. However, it’s important to remember that the journey doesn’t end there. The European Medicines […]
The Global Ambition
Don’t Sleep On The EU! The Global Ambition The rare disease landscape is evolving rapidly, with groundbreaking scientific advancements and novel therapeutic approaches emerging at an unprecedented pace. For biotech and pharmaceutical companies venturing into this dynamic space, navigating the complex regulatory pathways for approval in both the US and Europe is paramount. A well-orchestrated […]
EU As A Launch Pad
EU As A Launch Pad Think Global, Start European: A Strategic Launchpad for Rare Disease Therapies The global rare disease landscape is evolving rapidly, with increasing investment and a growing pipeline of innovative therapies. Yet, navigating the complex regulatory and market access pathways remains a significant challenge for biotech and pharmaceutical companies. In this context, […]
