RAPS

Study: Most drug products recouped development costs within a decade of approval

Between 1995 and 2014, a majority of new drugs and medicines approved by the US Food and Drug Administration (FDA) recouped the average cost of drug development through net discounted sales within a ...
Devdiscourse

Generative AI speeds up drug development, cutting time and costs dramatically

Bringing a single drug to market can take more than a decade and cost billions of dollars, with fewer than one in ten candidates successfully reaching approval. Against this backdrop, generative AI is ...
RAPS

Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies

FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and ...
BioSpace

Lean Derisking: Smart Ways to Cross Drug Development’s “Valley of Death”

Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early ...
Medscape

FDA Aims to Streamline Biosimilar Drug Development

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
PharmTech

FDA Reaches Key Goals for Reduction of Animal Testing in Drug Development

Key Takeaways. Draft guidance targets reduction/elimination of nonhuman primate testing for monoclonal antibodies, signaling higher regulatory receptivity to alternative nonclinic ...