Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Panel Nixes Tolvaptan On Weak Efficacy Data And Liver Risks

This article was originally published in The Pink Sheet Daily

Executive Summary

Small, unclear drug effect and hepatotoxicity take down Otsuka’s tolvaptan kidney disease indication at Cardiovascular and Renal Drugs Advisory Committee review.

You may also be interested in...



Keeping Track: Good News/Bad News For Pfizer; Filings For Brexanolone, Risankizumab

The latest US drug development news and highlights from our Performance Tracker.

Orphan Drug Spending: Could Sequence Of Indications Offer Pricing Policy Solution?

Focusing on orphan-first drugs may be best route to address pricing concerns, Health Affairs study suggests after finding that just one-fifth of spending on 15 top-selling partial orphan drugs was for the drugs’ rare disease indications.

US Remains Conservative On Vaccine Dosing Regimens As CDC’s ACIP Highlights Minimal Comfort With Relying On Unproven Correlates

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices concerns about making COVID-19 vaccine dose regimen changes based on unproven immune correlates of protection could be a warning sign to sponsors about roadblocks they might face if updating vaccines to address viral variants or conducting pediatric studies relying on such surrogate endpoints.

Topics

Related Companies

UsernamePublicRestriction

Register

OM007466

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