The US and the EU recently introduced regulation to curb the extent of risky off-label drug use. It offers manufacturers a prolongation of patent protection or exclusivity if they invest in pediatric clinical tests. This paper shows that a reinforcement of physician liability for off-label use...

We investigated the stock price behavior of public pharmaceutical and biotechnology companies upon approval of a drug by the Food and Drug Administration (FDA). Using event study methodology, we examine the reaction caused by the approval, separating it from the asset price movements caused by...