Personal investment isn’t a liability in biotech leadership, but rather, a competitive advantage, writes Lisa Ricciardi, CEO ...

GLP-1 therapies created a consumer-driven market for pharmaceuticals that pairs digital access, partnerships, and retention ...

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

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 ...

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 Originally enacted during the Civil War to ...

Spinning off a $4 billion biopharma business is no easy task. Integrated functions need to be separated, governance boards created, leadership teams assembled, and corporate headquarters established.

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 ...

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 ...

Biotechnology is all about scientific breakthroughs that lead to transformative therapies. But despite billions invested and years of R&D, data from Deloitte found that more than half of drug launches ...

In January 2024, the US-based global pharmaceutical company Lilly announced the launch of LillyDirect, a direct-to-patient portal that enables some patients to access drugs including its novel weight ...

Patient safety is the top priority for regulators. While the industry and the public advocate for alternatives to animal testing, regulators require strong evidence that alternatives are equally safe ...