Janssen’s Troy Sarich outlines why it’s hard to emulate randomized controlled trials with real-world evidence studies, emphasizing that the two are “not in competition.” He also highlights the huge strides made by AI-driven technology firms to provide “research-ready” structured data and new game-changing advances in the area of health sensors.

Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.

A high profile panel including the WHO's chief scientist and ministers of Norway and South Africa discussed critical dimensions pertaining to coronavirus vaccines and risks of a “pandemic within a pandemic” with the emergence of  SARS-CoV-2 variants. Funding gaps at the ACT Accelerator and extending the shelf life of vaccines were also deliberated.

Multiple COVID-19 vaccines, including from RDIF and Novavax, could get accelerated approvals in India in the first half of calendar 2021, expanding the range at the country’s disposal. J&J's vaccine is expected to follow although it still hasn’t begun local trials, while Pfizer has temporarily withdrawn an application.