By Emil Ciurczak, Contributing Editor

Sunday, January 22, 2012

 Read more...

Modified-release drugs are inherently more challenging to develop and manufacture. It stands to reason that applying Quality by Design methodologies to MR products is more challenging as well—but even more important in order to understand and control their quality and efficacy.

 Read more...

By Paul Thomas, Senior Editor

This month, the not-for-profit Regulatory Harmonization Institute was launched, with the mission of being a regulatory body to better represent the interests of emerging countries and “non-regulatory stakeholders.” (Read RHI’s press release here.) Founding members include BIO, the Generic Pharmaceutical Association (GPhA), and other notable global organizations, as well as representatives of AstraZeneca, Bausch & Lomb, and other major drug and device manufacturers. (See below for profiles of the organization’s leadership.)

 Read more...

By K.R. Karu, Industry Solution Director, Sparta Systems

[Editor's Note: This article originally appeared on the Sparta Systems Blog. Permission to republish has been granted by Sparta Systems.]

 Read more...

Just how far has pharma R&D productivity fallen? According to three Oliver Wyman analysts, very far indeed. They’re basing their conclusion on the number of new drug approvals vs. research dollars spent over the past several decades, and factoring in the value of new drugs launched each year. Since 2005, we’ve been in an “Era of Scarcity,” they say.

 Read more...

By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.

As this year comes to an end, it’s a good idea to take stock of the past year and look at where the pharmaceutical industry may be heading. Will the future mirror the past?

 Read more...