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

Truvada PrEP REMS Needs More Work, FDA Panel Says

Executive Summary

In a marathon meeting, the Antiviral Drugs Advisory Committee endorses use of Gilead’s emtricitabine/tenofovir fixed-dose combination for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection, but some committee members say Gilead’s REMS needs more “teeth,” including a linkage between a documented negative HIV test and access to the drug.

You may also be interested in...



Descovy, Truvada And The Politics Of PrEP

US FDA's advisory committee review of Gilead’s Descovy for pre-exposure prophylaxis of HIV wasn’t exactly free of controversy. But the meeting sure went more smoothly than the first PrEP review seven years ago.

Gilead's Descovy May Have Problem Getting HIV Prevention Indication In Cisgender Women

Descovy demonstrated noninferiority to Truvada in men and transgender women who have sex with men, but pharmacokinetic data do not support a demonstration of pre-exposure prophylaxis efficacy in cisgender women, US FDA says in advisory committee briefing document.

Moderna’s Pediatric COVID Vaccine Packaging Spurs Confusion Concerns From CDC Panel

Discrete packaging for authorized dose in 6-11 year-olds is not yet available, so vaccination providers have to use product from a vial labeled for ‘booster doses only’ in adults. ACIP members unanimously endorse use of the mRNA vaccine in individuals ages 6-17 years but urge manufacturers to move away from relying on color to differentiate formulations.

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS054433

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