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

Individualized genetic medicine is moving faster than the traditional drug approval model was built to handle. Genome editing, RNA-based medicines, and other targeted therapies can now be designed for ...

The global pharmaceutical supply chain has been under intense scrutiny since the COVID-19 pandemic exposed its heavy reliance on concentrated Active Pharmaceutical Ingredient (API) manufacturing hubs.

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 ...

Biotech has entered a new era of financial discipline. The days of easy capital, billion-dollar preclinical valuations, and “platform first, data later” investing have largely disappeared. Today, ...

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 ...

The era of outsourced regulatory work and rented thinking is ending. Agentic AI makes in-house capability inevitable, if leadership has the nerve to build it. Every biopharma CEO now claims to run an ...

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 ...

Europe produces extraordinary science. From RNA biology to immunology, many of the breakthroughs shaping modern medicine originate in European labs. But building a company around that science — ...

I was a medical student in Belgrade when a friend noticed an unusual object in the corner of my apartment. It was an American football, something I had carried back with me from years of living in ...

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 ...

Biotech is the most honest leadership environment in the world. Science does not soften bad news. Markets do not wait for leaders to feel ready. And the pressure does not lift between a failed trial, ...