Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Lowers Bar for Latest COVID Monoclonal Antibody Authorization

Executive Summary

Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.

You may also be interested in...



COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US

Five of the six modeling scenarios in the FDA’s quantitative benefit-risk assessment on myocarditis with Moderna’s vaccine assumed Omicron as the dominant circulating strain, with assumed average vaccine effectiveness of only 30% against COVID-19 cases and 72% against hospitalizations.

Biden’s ‘Test To Treat’ Plan Will Include Merck And Pfizer COVID Pills, But Only One Gets Public Thanks

Hundreds of pharmacy-based clinics and community health centers will offer free COVID testing and treatment. Government has secured 20 million doses of Pfizer’s Paxlovid, deemed to be a ‘game changer,’ though Merck’s molnupiravir is expected to be important in long-term care facilities.

Thinking Post-COVID: How Will US FDA Transition Drug, Vaccine EUAs To Full Approvals?

Sponsors seek clarity about the transition process, which could last a year or longer.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS145740

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel