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

In Case You Missed It: RWE, US FDA Commissioner Hearings, 2021 Approval Trends, And More

Executive Summary

Start the new year by catching up with these key stories posted by the Pink Sheet in late December.

You may also be interested in...



Pink Sheet Podcast: Trial Diversity, More PTAB Issues, US FDA Controlled Substance Leader Elevated

Pink Sheet reporter and editors discuss another project to improve clinical trial diversity in the US, the Patent Trial and Appeal Board director review process, and the FDA promoting its head of controlled substance policy to deputy CDER director.

Pink Sheet Podcast: Novavax Gets EUA, Califf Sets US FDA Departure, Hemophilia Patients Want REMS

Pink Sheet reporters and editors discuss the FDA’s latest COVID-19 vaccine emergency use authorization, activities during the FDA commissioner’s remaining time in office, and patients requesting a gene therapy risk management plan.

Pink Sheet Podcast: New Drug Pricing Bill, Second Amylyx US FDA Adcom, Skipping A Makena Vote

Pink Sheet reporters and editors discuss new changes to the Senate drug pricing bill, the FDA’s decision to call a second advisory committee meeting for Amylyx’s ALS drug, and Covis’ request to skip a vote during the hearing on Makena’s withdrawal.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS145454

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