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

Pink Sheet Podcast: Janet Woodcock And The US FDA’s G.O.A.T., Puberty Blockers Meeting, CAR-T Safety

Executive Summary

Pink Sheet reporters and editor discuss FDA Principal Deputy Commissioner Janet Woodcock’s place in the pantheon of FDA leaders, an agency meeting with stakeholders on puberty blockers, and a new boxed warning for CAR-T therapies.

You may also be interested in...



Aduhelm’s Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH

Pulling the controversial Alzheimer’s drug’s BLA should not exempt Biogen from fulfilling ClinicalTrials.gov reporting requirements for two key studies, even if the research gets terminated, former head of the NIH data repository tells the Pink Sheet.

New US FDA Genetic Metabolic Adcomm Needs More Candidates

Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

CMS Expects Part D Plans To Go To Great Lengths Facilitating Participation In New Copay ‘Smoothing’ Option

The Medicare draft guidance seems designed to ensure seniors don’t miss out on the IRA benefit. 

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149692

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