Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.

Environmental demands, the evolution of care models, new delivery technologies and AI tools are influencing how medtechs must approach innovation.

New markets, a patent cliff, an M&A rebound and clinical trial catalysts. How will it all play out for the biopharma sector in 2024? 

CBER director does not want to hold back potentially beneficial products, but also warned that patients will have difficult treatment decisions to make since an immune response might prevent a patient from receiving another gene therapy using the same vector ever again.