While Congress edged closer to a deal that would put the government back to work, the impact of the shutdown is piling up at the FDA even though it had carryover user fees to keep many of its activities moving for the past few weeks.
While the first biosimilars to hit the U.S. are still in development, the battle over how and when the follow-on biologics should be marketed continues to rage on both the local and global fronts.
Tired of getting no satisfaction from the federal government, California is rolling out its own drug safety legislation to increase the oversight of sterile compounded drugs.
Although the Supreme Court is just getting into the swing of its fall term, drugmakers seeking relief from escalating damage awards and shareholder lawsuits have already lost a few battles.
Despite rare Saturday sessions, the House and Senate appear to be spinning their wheels when it comes to ending a partial government shutdown that’s headed into its second week due to Congress’ inability to agree on fiscal 2014 funding measures.
With both the House and Senate refusing to be the first to flinch in their ongoing game of chicken Tuesday, the rest of America was getting a feel for how the first government shutdown in 17 years might affect their day-to-day businesses.
What’s in a biosimilar name? That depends on whether the vial is half empty or half full. Seeing it as half full, many generic makers focus on the similarities between a follow-on and its reference biologic. Because of those similarities, they say biosimilars and their reference product should share the same international nonproprietary name (INN) – as is the practice with traditional generic drugs. That’s the argument the Generic Pharmaceutical Association (GPhA) made in the citizen petition it submitted to the FDA earlier this month. Used to cashing in on the success of a small molecule brand drug by sharing...
