FDA’s final SIUU guidance loosens some off-label communication rules, but drugmakers still face strict compliance demands to ...

With AI, the tools are ready and the budgets are allocated, but they are flowing to the wrong places, write Romi Singh, Ph.D.

The commercial leader/board dynamic will matter even more as pricing pressures and policy complexity increase, writes Beren ...

On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and ...

On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits ...

In the increasingly complex world of artificial intelligence (AI), the concept of "correct outcomes" takes on a profound and sometimes ambiguous meaning. Although efforts are made to create AI that ...

Implementing AI in drug discovery offers significant potential for reducing operating costs, though the extent varies widely. A Deloitte report suggests AI could cut drug development costs by up to 70 ...

The False Claims Act (FCA) and the Anti-Kickback Statute (AKS) are two of the Department of Justice’s (DOJ) primary tools when it comes to fighting fraud. Originally enacted during the Civil War to ...

Managing third-party risk is one of the most arduous challenges facing pharmaceutical companies, and regulatory requirements are just one piece of this puzzle. Pharmaceutical organizations are ...

As pharmaceutical manufacturers grow, they often pursue external sources of innovation to supplement their own R&D efforts. A recent study found that 45% of drugs in the pipelines of 20 large ...

Speed alone no longer guarantees success; here’s what matters most in today’s launch environment. In today’s launch environment, order of entry (OOE) isn’t destiny. Many brands still anchor strategy ...

Conferences and trade shows are great places to learn about your competitive environment, as most companies in the industry usually attend these events; this includes competitors, suppliers, customers ...