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 ...

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 ...

Smart money will find good ideas, and if you follow the money in biotech these days, that means looking to China. From January to mid-May 2025, Chinese biotechnology companies had announced licensing ...

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 Originally enacted during the Civil War to ...

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 ...

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.

Industry Explorers Blaze On: A series of stories of longtime leaders, still active in the industry, sharing their historical perspectives on life sciences industry innovation. A consuming interest, ...

In the rapidly evolving world of life sciences, companies are constantly seeking ways to optimize their business structures to better navigate the complex landscape of drug development and financing.