FDA’s OPDP untitled letters show rising scrutiny of DTC ads’ overall impression on consumers and urge companies to balance ...

FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.

As emerging biotechs scale, procurement is becoming a key lever for patient access, resilience, and long-term commercial ...

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 ...

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 ...

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 ...

Ypsomed, a Swiss developer of injection and infusion systems, is making a significant move into North Carolina’s life sciences landscape with a $249 million investment in Holly Springs. This expansion ...

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 ...

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 ...

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 ...

Why did John Oyler, an American entrepreneur, decide to build a global biopharmaceutical company with roots in China? Ask the chairman, cofounder, and CEO of BeiGene that question and you’re going to ...

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 Originally enacted during the Civil War to ...