top of page

Case Studies

17 Mar 2023

Different regulatory approaches to gene therapy; the Bluebird story

How Bluebird Bio’s Gene Therapy Breakthrough Stumbled in Europe Despite Early Success in the U.S.

Read More
Different regulatory approaches to gene therapy; the Bluebird story

21 Mar 2023

Surrogate Markers vs. Clinical Outcomes: How FDA and EMA Diverged on Sarepta’s Duchenne Therapy

Inside Sarepta’s Battle to Bring a Groundbreaking Duchenne Therapy to Europe Amid Regulatory Roadblocks.

Read More
Surrogate Markers vs. Clinical Outcomes: How FDA and EMA Diverged on Sarepta’s Duchenne Therapy

22 Mar 2023

Different approaches to Biomarkers

Intercept’s Struggle: How Ocaliva Faced Diverging Regulatory Hurdles on Its Path to Global Approval.

Read More
Different approaches to Biomarkers

19 Mar 2023

Navigating Safety Standards: How Aimmune Faced Differing FDA and EMA Requirements for Peanut Allergy Therapy

Aimmune’s Journey: The Challenges of Bringing a Revolutionary Peanut Allergy Therapy to European Markets.

Read More
Navigating Safety Standards: How Aimmune Faced Differing FDA and EMA Requirements for Peanut Allergy Therapy

Contact Us

Thanks for submitting!

bottom of page