Convalescent Plasma EUA Will Not Complicate Hyperimmune Globulin Product Development, Sponsors Say

US FDA authorization will further boost already-high demand for plasma from individuals recovered from COVID-19 and increase competition for donors, NYU’s Arthur Caplan predicts, but CoVIg-19 Plasma Alliance and Emergent BioSolutions say they do not expect EUA to impact either product supply or enrollment in upcoming randomized trials of their H-Ig products.

Packages with donated plasma and blood
EUA may boost demand for convalescent plasma and competition for donors. • Source: Shutterstock

The US Food and Drug Administration’s emergency use authorization for COVID-19 convalescent plasma is not expected to complicate industry efforts in the US to develop pharmaceutical-grade hyperimmune globulin products made from the same material, industry representatives say, despite one expert’s concerns to the contrary.

New York University bioethicist Arthur Caplan predicted the EUA will further boost demand for much-needed plasma from individuals who have...

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 Clinical Trials

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By 

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

More from R&D