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

Big Pharma's Winning Formula: Many Approvals, Narrow Markets

Executive Summary

FDA's drug center posted yet another record-breaking year for novel approvals, clearing 45 new molecular entities and therapeutic biologics, with big increases in orphan drug and breakthrough therapy approvals but few me-too drugs for common conditions. Is pharma's focus on unmet needs shortchanging public health?

You may also be interested in...



A Pathway, Not A Shortcut: 505(b)(2) NDAs Have Longer Reviews Than NMEs

US FDA's argument that its review resources favor novelty/medical advances could be buttressed by Tufts Center for the Study of Drug Development analysis of (less novel) approvals using the streamlined 505(b)(2) NDA pathway.

Keeping Track: CDER 2016 Novel Approvals Hold At 22 As US FDA Declines Cempra's Solithera

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

More Me-Too Drugs Please, FDA’s Jenkins Asks Industry

FDA’s top new drug official called out industry’s innovation model, noting that major primary care markets are being left underserved as sponsors focus on precision medicine and rare diseases.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS057350

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