Article preview from “The Pink Sheet”-  April 4, 2011 The six-year battle over patent reform legislation is not yet over as the pharmaceutical and biotechnology industries and other leading stakeholders are unhappy with provisions in the House bill that differ from the recently passed Senate measure. House Patent Reform Bill: Battle Looms Over Reexam, Prior User Rights

House Patent Reform Bill: Battle Looms Over Reexam, Prior User Rights ProvisionsRead More »

Article preview from “The Pink Sheet”-   March 28, 2011 Many industry watchers were surprised when the Centers for Medicare and Medicaid Services conducted an extensive evidence analysis of ESAs, only to propose on March 16 no policy change. Indeed, the outcome, if made final, would be quite unusual, a look at numerous coverage analyses shows. A

A Closer Look: Decision For No Medicare NCD On ESAs In Renal Disease Would Be The ExceptionRead More »

“One area of criminal enforcement that will be a focus for the Criminal Division in the months and years ahead [is the] application of the Foreign Corrupt Practices Act (FCPA) to the pharmaceutical industry. We will be vigilant in holding companies and individuals who break the law accountable, not only through civil actions … but

“Pharma and Device Companies are the Next Target for FCPA Investigations”Read More »