The Trump administration disrupted the typically sleepy August recess with a frenetic release of proposals that implement components of its “Blueprint” on drug pricing. Physician and patient advocates expressed concern that these proposals may result in impaired patient access to needed drug therapy.

In this article, we review select NDA terms that you may want to carefully tailor in each biotechnology-related NDA, including the format, key definitions, and term of the agreement.

When Celgene began pursuing an aggressive acquisition strategy, David Stirling, Ph.D., a cofounder, decided to leave and eventually start his own company, BioTheryX.

Considering words matter in helping society foster empathy instead of socially distancing themselves, perhaps we could find neutral, empowering language that still establishes unmet needs and urgency.

The unusual story of how Apellis was formed and what led it to target C3, the central factor in the innate-immunity complement system, to treat autoimmune diseases — starting with the ultra-rare blood condition, PNH.