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…
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…
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…
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…
Bringing Cell Therapies to Rare Disease Patients in Europe Rare diseases are defined by sheer numbers of new patients per population. This definition is not helpful for the affected patient and his/her…
Hope for Rare Diseases Drug Repurposing for Better Patient Care in Europe For patients with rare genetic diseases, the struggle extends far beyond the challenges of the disease itself. Multiple co-morbidities often…
The Global Landscape of Rare Disease Treatments Legal and Regulatory Considerations for Pharma and Biotech Companies Rare diseases, affecting a small percentage of the population, often face a lack of research funding…
Ensuring Patient Access The Crucial Role of Market Access for Drugs Navigating the journey from clinical trials to market access requires a deep understanding of the European landscape. Partner Rare’s team of…
Navigating Gene Therapy Commercialization in Europe A Q&A with Joshi Venugopal, General Manager of Gene Therapies and Rare Diseases, Europe Opinions expressed here are personal and not that of Novartis* Gene therapies…
Rare Disease Clinical Trials A Collaborative Approach to Design and Execution Patients who suffer from rare diseases need access to effective and safe medications. Given the low incidence of the diseases, the…
Demystifying The Maze Centralized vs. National Procedures for Rare Disease Drug Registration in the EU Introduction The European market presents a compelling opportunity for US pharma and biotech companies developing life-changing therapies…
Cracking the EMA Code Expanding into Europe Expanding a Rare Disease drug’s marketing authorization into Europe can potentially increase a company’s net worth, but it’s not a guaranteed outcome. Here’s a breakdown…
The Geopolitics of Hope A Flourishing Market, Yet Millions in Europe Lack Access to Rare Disease Treatments Did you know that over 30 million people in Europe live with a rare disease,…
Your gateway to successful rare disorder asset commercialization in the European market.
