No big worries appear to be on the agenda for Thursday’s advisory committee meeting on Janssen Pharmaceuticals Inc.’s simeprevir, which is seeking a limited hepatitis C virus (HCV) label.
Given the power of a name and the fact that more biosimilars are moving through the global pipeline, the World Health Organization (WHO) is facing increased pressure this week to come up with a new international nonproprietary naming (INN) scheme for the follow-on drugs.
The good news is that the government is up and running again and a default on federal bills has been averted for at least another few months. The bad news is that government agencies, including the FDA and National Institutes of Health (NIH), are once again pinned to last year’s sequestered spending levels.
Too much information, SEC Chairwoman Mary Jo White said as she bemoaned the disclosure overload that’s the byproduct of regulation, social media and a litigious environment.
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.
