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 ...

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

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 world of biopharmaceutical innovation, groundbreaking scientific discoveries often do not directly translate into commercial success. Simply developing a promising therapeutic based on great ...

It was the summer of 2007 when Chris Anzalone, Ph.D., got a call from Arrowhead Research Company. At the time, Anzalone was working as CEO of the Bennet Group, a private equity firm in Washington, D.C ...

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 ...

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 ...

Marc Richards Biotechnology companies often offer a promise of future success, but it can take years to determine whether all the effort (and expense) will translate into returns. Because of the ...

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.

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 ...