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 ...

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 ...

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 ...

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 ...

Drug and device manufacturers have long sought clearer rules for sharing scientific information about unapproved (off-label) uses of their products with health care providers (“HCPs”). In January 2025 ...

Achieving regulatory approval for a new drug is an extraordinary achievement. The bar for success is high. Many companies with breakthrough scientific discoveries and promising clinical data still ...

For much of the past two decades, the geography of pharmaceutical innovation was relatively stable. Discovery and capital clustered in hubs such as Boston, San Diego, and Basel. Asia played an ...

In the realm of pharmaceutical patent litigation, settlement agreements between branded and generic pharmaceutical companies are frequently used to resolve disputes before, during, and after trials in ...