PRIME Dry Spell Ends As EMA Takes On Eye Disease Gene Therapy

The first designation of 2018 under the European Medicines Agency’s PRIME scheme has gone to an advanced therapy for patients with the severe eye disorder, achromatopsia. In the meantime, most PRIME applications are still getting rejected.

Human eye
The EMA has accepted a gene therapy for an eye disorder onto PRIME • Source: Shutterstock

The European Medicines Agency has for the first time in three months accepted a product onto PRIME, its popular development support scheme for medicines addressing an unmet medical need – an investigational gene therapy for the eye disorder, achromatopsia.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Review Pathways

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

African Medicines Agency Set To Launch With New Leader In April

 

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

AMR-Targeting Drug Secures EMA PRIME Designation

 

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

More from Pathways & Standards

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

African Medicines Agency Set To Launch With New Leader In April

 

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.