Tag Archives: Legal

U.S. Biosimilars Under Threat?

By Guest Blogger | Published: April 27, 2012
by D’vorah Graeser, Graeser Associates International While the FDA continues to develop its guidance for U.S. biosimilars, including a one-day public hearing on May 11, 2012, the basic legal underpinnings of biosimilars in the U.S. may be under threat, as the Supreme Court debates the healthcare law, a large chunk of which includes provisions for biosimilars.
Posted in Biotech, FDA, Guest Blog, IP, Legal, Regulatory, Strategy, Technology | Also tagged , , | 1 Comment

Justice to Pharma: "Do the Perp Walk!"

By Walter Armstrong | Published: November 17, 2010
Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next? The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and [...]
Posted in Legal, Strategy | Also tagged , , , , | 4 Comments