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

 
• By Brenda Sandburg

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.

Monoclonal antibody
CytoDyn video promotion for its investigational COVID-19 treatment draws FDA warning letter • Source: Alamy

For the second time in a year, the US Food and Drug Administration has reprimanded CytoDyn, Inc. for making claims about the efficacy of its investigational drug leronlimab for treatment of COVID-19. The agency went further this time, with the Office of Prescription Drug Promotion issuing a warning letter to the company demanding that it submit a plan to disseminate a corrective communication.

In a 11 February letter, OPDP objected to a video interview in which then CytoDyn president and CEO Nader...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 
• By Sarah Karlin-Smith

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
• By Cathy Kelly

Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.