A citizen watchdog group is again raising concerns about conflicts of interest on FDA advisory committees, charging that the agency should not have allowed a panel member to vote on a drug that a family member was taking. Read More

U.S. lawmakers Dec. 11 introduced legislation that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More

The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing earlier this month that outlines how it intends to approach one contentious issue involving compounders. Read More

GlaxoSmithKline unveiled a new compensation system for its global sales force this week in a move hailed as a revolutionary change to improve ethical practices for drug sales professionals. But so far it’s a revolution of one. Read More

HHS stands by its final rule expanding 340B discounts to orphan drugs when certain hospitals and healthcare providers use them to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More

The Senate last week voted 64-36 to approve a budget that will protect FDA user fees from sequestration cuts for the next two years. Read More

Former InterMune CEO W. Scott Harkonen’s crusade to challenge his felony conviction in a closely watched free speech case collapsed after the Supreme Court declined to hear his appeal. Read More

French authorities on Thursday fined Merck $21.5 million for its efforts to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More

The FDA will allow Ariad Pharmaceuticals to resume U.S. sales of its leukemia drug Iclusig, but the drugmaker must now implement a host of stringent safety measures designed to address the drug’s risk of blood clots. Read More