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

What Astellas Did Right In Using Real-World Evidence For Prograf Approval

Executive Summary

US FDA’s John Concato cites rigorous collection of data and study design in getting Prograf lung transplant indication. Use of real-world evidence in Opdivo trials had mixed results, BMS exec notes.

You may also be interested in...



Keeping Track: US FDA Clears Vaxneuvance, Rezurock And Karendia, But Not Teplizumab

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

Keeping Track: US FDA Approvals Include Novel Agents Zepzelca And Uplizna, Biosimilar Nyvepria, Follow-On Semglee

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

Merck’s Molnupiravir Open License With Medicines Patent Pool May Be Model

Pharma industry critics herald the agreement for allowing many manufacturers around the world to make the COVID-19 therapeutic and for its transparency. If Merck can do it, they ask, why can’t other companies?

Topics

Related Companies

UsernamePublicRestriction

Register

PS144967

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