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

Pharma Innovation Is Highest Where It Matters Most, FDA Analysis Shows

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A new system of measuring innovation in new drugs proposed by analysts from FDA’s Office of Planning paints a rational picture of drug development oriented by medical need, with the greatest innovation in serious and life-threatening conditions.

You may also be interested in...



What Innovation Crisis? First-In-Class Drug Approvals Stable For Almost 25 Years, FDA Says

An FDA study evaluating NMEs by level of innovation finds level first-in-class approvals to be consistent, and approvals after the study period reinforce “encouraging” findings. Analysis says new metric should be basis for assessment of programs created by FDASIA to speed development of innovative products.

Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116

As Merck’s 21-valent vaccine approaches its 17 June user fee goal, the US CDC’s vaccine committee is looking at new adult age-based recommendations and bracing for a full pipeline led by GSK’s 24-valent candidate.

US FDA Expects Joint AdComm Briefing Document, Oncology Chief Says

The combined format is the new default for briefing advisory committee members, US FDA Oncology Center of Excellence Director Pazdur declared.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS005262

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