After decades of racing to the bottom on pricing, a revolution is coming to the U.S. generics market, writes Yaral Pharma CEO ...

Advocacy for alternatives to animal testing in clinical research is pushing the industry away from animal-based endotoxin ...

Experts at Faegre Drinker offer life sciences business planning and risk mitigation strategies to consider in response to ...

Modern drug development approaches that integrate functional plans with larger business goals are needed for success in early ...

Vivani Medical is developing GLP-1 subdermal implants that aim to provide a consistent therapeutic dose for six months, and ...

Essential medicines play a vital role in America’s health, and the supply is closely monitored by the FDA and industry groups. These medicines sustain life, provide life support and/or the prevention ...

In many ways, it makes sense for Big Pharma to in-license promising pipeline candidates from smaller companies, effectively using them as an innovation engine and source for pipeline renewal. However, ...

The False Claims Act (FCA) and the Anti-Kickback Statute (AKS) are two of the Department of Justice’s (DOJ) primary tools when it comes to fighting fraud. Originally enacted during the Civil War to ...

In the dynamic pharmaceutical industry, successful product launches are critical to business success. For small and midsized biotech firms, where the reliance on a few key assets is high, the stakes ...

A substantial share of biopharmaceutical drug launches (>50%) fail to meet their projected analyst forecasts (see also Simon-Kucher Biotech industry study 2019). With considerable investment going ...

The life sciences industry contributed nearly $4 billion to the U.S. economy in 2021 and is expected to continue growing an average 7% to 8% per year over the next five years. With an increasing ...

The number of psychedelic drug developers reaching Phase 2 and Phase 3 clinical trials is growing, in recognition of the level of unmet need in many mental health disorders and other conditions. Those ...