GLP-1 therapies created a consumer-driven market for pharmaceuticals that pairs digital access, partnerships, and retention ...

On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and ...

On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits ...

FDA’s final SIUU guidance loosens some off-label communication rules, but drugmakers still face strict compliance demands to ...

With AI, the tools are ready and the budgets are allocated, but they are flowing to the wrong places, write Romi Singh, Ph.D.

The commercial leader/board dynamic will matter even more as pricing pressures and policy complexity increase, writes Beren Therapeutics Bennett Smith.

Manufacturing environments are under pressure to become more adaptable, data-driven, and scalable without adding unnecessary complexity. The Module Type Package (MTP) approach offers a practical path ...

Bringing a therapy from early research to patient delivery requires more than innovation—it demands coordination, data integrity, and scalable operations at every step. Explore how an end-to-end ...

On this week's episode of the Business of Biotech, we talk with NervGen leaders Adam Rogers, M.D., and Rich Macary about NVG-291, a daily neuroreparative peptide designed to restore function in ...

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 ...

A Germany-based biopharmaceutical company marketing products across Europe was facing increasing complexity in managing its global pharmacovigilance (PV) operations. With oversight of more than 2,300 ...