In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Gaining regulatory approval for drugs targeting conditions that cannot ethically be studied in humans presents a unique ...

Progress in computing has long been described by Moore’s law, a rule of thumb which says that the cost of processing power falls by half roughly every two years. The pharmaceutical industry follows an ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

This article summarizes a discussion at LSX Biopharm America on September 11. A panel of industry experts discussed approaches to overcoming the most urgent CMC challenges during the discussion. The ...

The Congressional Budget Office (CBO) informs Congress about the costs or revenue changes associated with proposed legislation, a challenging enough task on its own. Sometimes, the CBO is asked to ...

Pharmaceutical companies often choose not to advance drug candidates for business reasons, rather than because of safety or efficacy concerns. These compounds could still help some people, so biotech ...