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

CytoDyn’s Promotion Of Investigational Drug Leronlimab Once Again Rebuked By US FDA

Executive Summary

OPDP warning letter objects to video interview in which CytoDyn's then CEO touts use of the investigational drug for COVID-19. The exec says he is ‘making up numbers’ but if the pattern continues there will be ‘the most fantastic results’ anybody could ever imagine.

You may also be interested in...



AstraZeneca Gets Rare Warning Letter Over Breztri Sales Aid; Footnotes Don’t Balance Graphics

Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.

Social Media: Use Of Influencers In Drug Promotion Requires Guardrails, Experts Say

Careful identification and vetting of spokespersons, training on FDA regulations, and development of content that conveys the typical patient experience are keys to successful and compliant influencer campaigns, advertising, legal and regulatory experts told a recent DIA conference.

Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Related Content

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145738

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