Burnout is not an individual failure: it’s a systems imbalance, biologically and organizationally, write Tony Martignetti and ...

On this week's episode of the Business of Biotech, Bruce Culleton, M.D., CEO at ProKidney, talks about moving from academic research to industry and the role a key mentor played in his career path.

Recently, there has been heightened focus on dual brand approaches in which the same molecule is approved for multiple indications and packaged, priced, and distributed under different brand names.

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 ...

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.

“THAT WAS A TERRIFYING MOMENT,” reflects Matt Patterson, cofounder, chairman, and CEO of Audentes Therapeutics, a genetic medicines company focused on the adeno-associated virus (AAV). It was the fall ...

Essential medicines play a vital role in America’s health, and the supply is closely monitored by the FDA and industry groups. These medicines sustain life, provide life support and/or the prevention ...

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 Originally enacted during the Civil War to ...

In a complex global and competitive world, formulating a plan without testing it against likely external reactions is the equivalent of walking into a battlefield without the right weapons or a plan ...

“I don’t care where you place me, but just make sure it’s terrifying,” was the last input I gave when my company, Novo Nordisk, was determining my job swap for the next year. So when I first learned ...

When working groups at AbbVie first began evaluating the use of digital technologies in clinical trials, the discussions were mostly conceptual. Individuals agonized over the right approach, the ...

In a few short years, Novo Nordisk has gone from belt-tightening to parachute pants, and is now replaying a GLP-1 competition with Eli Lilly that kicked off with Victoza and Trulicity ten years ago.