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De-Risking Headline Risk: Merck Media Strategy Helps Company Ride Out ARBITER Data

This article was originally published in RPM Report

Executive Summary

A negative, head-to-head study questioning the role of Vytorin is presented at AHA: that sounds like a replay of the ENHANCE disaster. But here's the twist: Merck shares rallied after the data were released. What changed?

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FDA's Great(er) Expectations: Avoiding a Refuse-to-File in a New Review Environment

Each year, FDA rejects just a handful of new drug and biologics applications that aren’t quite complete enough for review. Now the agency’s revamped review process is forcing its staff to take a closer, earlier look at new submissions. Merck’s Zetia/Lipitor "refuse to file" letter is a case in point. Unless things improve, Office of New Drugs Director John Jenkins says, industry can expect more early rejections from FDA.

FDA's Great(er) Expectations: Avoiding a Refuse-to-File in a New Review Environment

Each year, FDA rejects just a handful of new drug and biologics applications that aren’t quite complete enough for review. Now the agency’s revamped review process is forcing its staff to take a closer, earlier look at new submissions. Merck’s Zetia/Lipitor "refuse to file" letter is a case in point. Unless things improve, Office of New Drugs Director John Jenkins says, industry can expect more early rejections from FDA.

The Slow Death of a Blockbuster

Bad news continues to mount for erythropoiesis-stimulating agents (ESAs), the flagship products of the biotechnology industry. Far from developing new markets, postmarket clinical trials by Amgen and J&J continue to point towards a much smaller appropriate patient population for Aranesp and Procrit.

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