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

Antithrombotics: In A Crowded Field Of Candidates, Does Being First Matter?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The cresting wave of novel antithrombotic NDAs could mean 2010 will be a difficult year for FDA's Division of Cardiovascular and Renal Products, as the products have massive applications and tricky risk-benefit evaluations.

You may also be interested in...



For NMEs, The Song Remains The Same: Specialty Markets Eye Further Growth For 2010, While Traditional Big Pharma, Primary Care NDAs Are Few

The outlook for novel drug and biologic approvals in 2010 is strikingly similar to the beginning of 2009: specialty markets continue to gain ground on new products for primary care, and specialty firms continue to gain in the ranks of sponsors while big pharma struggles to put up successful new candidates.

For NMEs, The Song Remains The Same: Specialty Markets Eye Further Growth For 2010, While Traditional Big Pharma, Primary Care NDAs Are Few

The outlook for novel drug and biologic approvals in 2010 is strikingly similar to the beginning of 2009: specialty markets continue to gain ground on new products for primary care, and specialty firms continue to gain in the ranks of sponsors while big pharma struggles to put up successful new candidates.

Effient Review Delayed More By Management Issues Than Clinical Disputes

In FDA’s review of Lilly/Daiichi Sankyo’s antiplatelet agent Effient (prasugrel) – a drug with broad potential use – it is notable that the approval was delayed not by unusual clinical questions, but rather by the agency’s efforts to be exceedingly thorough and scrupulous in the review.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS004355

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