Global Compliance: Domino Effect
May 1st 2006In february, local news papers in the United Kingdom reported on disciplinary judgments made by the Association of the British Pharmaceutical Industry (ABPI) against four pharma manufacturers. The disciplinary actions consisted of public reprimands for three companies, and suspension from the association for at least six months for the fourth company.
Pharm Exec Q&A: Japanese Wedding
May 1st 2006Just how traditional marriages join a couple together from a common culture, Daiichi and Sankyo are merging based on a sense of having come from the same place, and facing the same future. But the art of integration lies in creating new ways of working that make the marriage bigger than the sum of its parts. Officiating the marriage is John Alexander, MD, head of pharma development for Daiichi Sankyo.
Why COX-2 Inhibitors Hurt the Heart
April 26th 2006A new study details the physiological reasons why COX-2 inhibitorsincrease the risk of heart disease. Suppressing the production of one key fact does reduce pain, but it also deprives the body of a mechanism to curb blood clots, resist artery hardening, and regulate blood pressure.
Court Says Agency Must Decide on Generic HGH
April 26th 2006A federal district court ruled that FDA cannot fail to rule on a Sandoz's application for approval of omnitrope, a human growth hormone, just because it has no policy for generic biologics. Court watchers say the decision may help other generic biologics move forward in the approvals process.
Media Spend Trends: Change the Channel
April 1st 2006It's not closing time, but it does seem like the nine-year, direct-to-consumer (DTC) advertising happy hour is winding down. PhRMA's new Guiding Principles are dimming the lights, and television, the most glamorous and visible media channel for DTC, will have to turn down the volume.